令和 4 年度
ＡＩ･モバイル用アプリケーション等
最先端医療機器調査等事業報告書

令和 5 年 3 月

国立医薬品食品衛生研究所
医療機器部

山本栄一

目次

1.

背景及び目的 ································································································ 1

2.

海外の開発及び薬事規制状況 ··········································································· 3
2.1 はじめに ································································································ 3
2.2 米国 ······································································································ 3
2.3 欧州 ······································································································ 8
2.4 中国 ······································································································ 9
2.5 韓国 ···································································································· 10
2.6 ロシア ································································································· 11
2.7 各国における AI を利用した SaMD の開発状況 ··········································· 113.

国際標準化状況 ··························································································· 124.

国内における開発及び薬事規制状況 ································································ 13
4.1 SaMD の承認状況及び関連情報 ································································ 13
4.2 SaMD 産学官サブフォーラム 2023 を通じた薬事規制上の課題抽出と整理 ········ 15

5.

まとめ ······································································································· 176.

参考文献等 ································································································· 18

参考資料① 海外の実態調査に関する報告書·································································· 21② 各国で販売等が確認されたプログラム医療機器リスト ··································· 45③ SaMD 産学官サブフォーラム 2023 発表資料 ················································· 75④ SaMD 産学官サブフォーラム 2023 参加者アンケート結果 ······························· 97

1. 背景及び目的
近年、機械学習（Machine Learning：ML）に基づいた AI を利用した様々なプログラム医療機器（Software as a Medical Device：SaMD）である ML 利用 SaMD の開発が活発となっている。特に、画像診断支援 SaMD の研究開発は世界中で活発に行われ、米国においては 2018
年以降、数多くの SaMD が Food and Drug Administration (FDA) により承認されている。これらの製品の中には、近年注目されている ML 技術の一つである深層学習を利用した製品の承認数も増加していることが確認される。しかしながら、当該製品のその大半が 510(k)で承認されており、FDA ホームページ（HP）で公開されている審査報告書では実際に主たる機能の原理に ML を使用しているか判別不明なケースが多い。すなわち、AI を利用した
SaMD、あるいは AI/ML 利用 SaMD と記載されている場合は古典的 AI 技術の古典 AI を利用した SaMD と ML 利用 SaMD が混在した状態となっており、そのため後者の承認数に関する実態は不明である。また、ML 利用 SaMD の開発は米国以外の国でも活発である。北米
放射線学会における展示ブースの出展状況に関して把握できた情報では、欧州製品に加えて中国及び韓国から数多くの企業が参加していたとのことから、両国における当該 SaMDの開発が活発であることが窺える。
本邦においては、2018 年に大腸内視鏡診断支援プログラムである EndoBRAIN が ML 利
用 SaMD として初めて承認された（サポートベクターマシンをアルゴリズムに使用）。その後も深層学習を含む複数の ML 利用 SaMD が承認されているが、その数を単純に比較すると欧米と比べて少なく、規制対応が遅れているという意見が目立っている。しかしながら、ML 利用 SaMD に特化した薬事体制の構築の有無や、どのような法規制下でその開発促進が進められているか等の情報収集及び整理がなければ、ML 利用 SaMD に関する本邦との比較は困難である。
上述したとおり、AI/ML 利用 SaMD という用語の定義が曖昧なため、本報告書内では関連する用語を以下のように定義して使用する。
•

SaMD：プログラム医療機器（古典 AI、あるいは ML 利用の有無を問わない）•

AI：一般的な「人工知能」（アルゴリズムの種類は問わない）•

AI/ML 利用 SaMD：利用技術が古典的か ML かの区別が困難な AI が利用されている
SaMD•

ML 利用 SaMD：明確に ML が利用されている SaMD
米国においては、各種 SaMD の製品化を促進するために、Precertification (Pre-Cert) pilot

program 実施 [1]、Discussion paper の発行と業界からの意見集約 [2]、その結果に基づいた
ワークショップの開催及び意見交換 [3]、その議論に基づいた Action plan の公表 [4] と矢継ぎ早に様々な施策を講じてきた。2022 年、Pre-cert プログラム試行結果を取りまとめた報告書が FDA より公表された [5]。これらの精査は本邦における SaMD、特に ML 利用 SaMDに利用可能な新たな規制枠組みを考察する上で非常に参考になるため、関連文書も含めた－ 1 －調査を進める必要がある。一方、言語的な問題はあるが、米国以外の国における AI/ML 利
用 SaMD に対する薬事の枠組みの調査も必要となる。
そこで、本事業においては、昨年度に引き続き、諸外国、特に米国における ML 利用 SaMDの開発、並びに規制状況を調査すると共に、本邦の規制において今後必要となる対策について考察した。また、本邦における SaMD、特に ML 利用 SaMD の開発状況共有と産学官関係者の意見交換を目的に経済産業省主導で開催された第 2 回 SaMD フォーラムに引き続き
SaMD 産学官サブフォーラム 2023 を開催し、第 2 回フォーラムで取り上げられたテーマを掘り下げた産学官関係者による総合討論を行うと共に、アンケートを実施して保険償還やデータの利活用に関する課題等の把握を試みた。

－ 2 －2. 海外の開発及び薬事規制状況
2.1 はじめに諸外国における ML 利用 SaMD の開発及び規制の実態については、米国以外の公開情報が少ないだけでなく、言語的な問題から調査が困難な国が多いことから、昨年度はその調査をインターテックジャパンに委託した。今年度は、昨年度の調査が不十分であった米国における SaMD 審査の実態を中心にインターテックジャパンに改めて調査を委託した（参考資料①）。その報告の概要と考察を以下に記載する。なお、以降に記載した製品の承認数等、各種データは調査報告書（参考資料①）が納品された 2022 年 9 月までのデータであることに留意されたい。
2.2 米国2.2.1 背景2022 年は、FDA による SaMD の規制について動きがあった年となった。2017 年に始まったデジタルヘルスツールの審査の迅速化による早期実用化を目的とした Precertification（PreCert）プログラムの結果報告に相当する文書である “The Software Precertification (Pre-Cert)
Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings” [5] が 2022 年 9 月に公表された。
当該文書によると、現状の規制枠組みに Pre-Cert を取り込むために更なる検討を要するという結論を示すのみに留まっていたことから、人材等が豊富な米国でも、特に市販後の追加
学習（市販後学習）により性能を変更することが可能な ML 利用 SaMD の社会実装の実現には予想以上の時間を要することが窺える。その点について考察を加えると共に、調査で示された FDA による SaMD 審査状況について本邦の現状と比較検討を行った。
2.2.2 FDA による SaMD への対応a) 医療機器に対する審査概要
米国における医療機器の承認審査は FDA が担当しており、本邦と同様、使用時の不具合に応じたリスクの大きさに応じて 3 段階（クラスⅠ、Ⅱ、Ⅲ）に分類されている。
クラスⅠに相当する医療機器の殆どは 510(k)による審査からも免除されている。
一方、一部のクラスⅠ機器とクラスⅡ機器は 510(k)の対象となり、使用目的、技術的特性、及び性能試験の点で、既存の機器と「実質的に同等」であることを証明する必要がある。
クラスⅢ機器の大半は市販前承認（Pre-market approval: PMA）の対象となり、治験の実施を要求される場合が多く、機器の使用目的に対する安全性及び有効性が合理的に保証されていることを示す有効な科学的証拠の提出が要求される。
そのため、クラスⅡ以上の機器は、米国の法律で定められた規制要件を満たしているか
FDA による審査を受け、510(k)、あるいは PMA を得て市場に流通することになる。
510(k)による審査対象は、完全な新医療機器ではなく、申請対象となる医療機器の使用時における安全性及び有効性が、既承認品と実質的に同等であることを実証できる製品であ－ 3 －る。具体的には、①「既承認品と同じ意図する使用方法と技術的特性を有すること」、②「既承認品と技術的な特性は異なっているが、意図する使用方法は同じであり、安全性及び有効性についても同等であることが実証され、新たな問題が生じないと考えられること」のいずれかを満たす必要がある。
本邦における認証制度に似ているが、米国では本邦における「認証基準」は存在せず、申請内容を適宜判断して、既承認品での手順と同様の審査方法を適用している。
市販前承認（PMA）は、最もリスクの高いクラスⅢの医療機器における安全性及び有効性
を FDA が審査及び評価するプロセスである。
PMA の審査プロセスは、以下の 5 段階から構成されており、本邦の承認審査と同様である。
① 書類確認（審査に必要な書類が揃っているか等の確認）② 審査員による規制要件に則った科学的観点及び品質観点による審査③ 諮問委員会による審査と勧告④ 最終的な審議、文書化及び FDA による審査結果の通知⑤ 製造工程における品質マネジメントシステムに関する監査・審査2018 年 12 月に設けられた De novo プロセスは、前述したように新しい原理やコンセプトを有する製品で類似の既承認品がないがリスクが軽度から中程度であり、クラスⅠ又はクラスⅡに分類される可能性がある新医療機器を対象にしている。
この De novo プロセスは、以下に該当する場合に申請可能となる。
・ 510(k)を申請し、参照した機器と実質的に同等でないと FDA に判断された場合
・ 申請者が、実質的に同等と判断できる類似の既承認品が存在しないと判断した場合
De novo 申請においては、その安全性と有効性を合理的に判断するために提出された書類に基づき、FDA が審査対象の機器をクラスⅠ又はクラスⅡと決定した後、510(k)相当の審査が実施される。申請が一旦受理された場合でも、事後に FDA から審査に必要な追加情報を要求されることや申請を却下される場合もあるが、承認された場合には、新たな医療機器分類が作成され、必要に応じて審査規則が設けられる。結果として De novo プロセスを経た機器
は、510(k)における既承認品としても利用することができる。
b) SaMD の審査
AI 利用の有無にかかわらず、
SaMD の審査は従来の機器と比較して大きな違いはないが、往々にして類似の既承認品が存在しないこと、リスクは軽度から中程度であるため大半がクラスⅠ又はクラスⅡに分類されること、その安全性及び有効性が合理的に保証される可能性があること等から De novo プロセスが適切となることが多い。しかしながら、AI、特に－ 4 －ML を利用した場合には、申請前に FDA との相談を実施するよう要請が出されている。この事前相談は、PMDA の相談業務と同様、技術革新が急速でそれに合わせた規制枠組みの変化も要求される SaMD の承認審査を迅速に進めることを目的としている。一方、相談内
容を申請企業に対して個別にフィードバックしていることもあり、包括的な審査制度の構築は進んでいないように思われる。事実、審査部門毎に AI を利用した SaMD の解釈が微妙に異なっているようであり、定義が完全に一致していない場合でも特定の製品コードで包括的な該当性を認めて 510(k)申請が可能になっている場合もあれば、個別の製品コードを規定するために、違いが僅かでも認められれば類似性を認めず De novo 申請を要求されることもある。
参考資料①では、FDA Database of Artificial Intelligence and Machine Learning (AI/ML)-Enabled
Medical Device、Medical Device AI Evaluation, The Medical Futurist を調査した結果、2021 年 6月までに AI/ML 利用 SaMD 359 製品が承認されていることが判明した。これだけの数の製品を承認しているにもかかわらず、SaMD を示す製品コード 40 種類から ML 利用の有無を特定できないことが調査業者より追加報告された。すなわち、米国における深層学習を含めた ML 利用 SaMD の承認実態を明らかにすることは困難であった。
報告書に記載された承認製品数の内訳を見ると 359 製品中 244 製品が放射線関係の SaMD
でその大半を占めていた（参考資料①の Figure 1 を参照）
。その後、2022 年 3 月時点で放射線関係の SaMD は 40 製品が承認されていることも提供された情報より明らかとなったが、いずれの情報からも ML 利用 SaMD の抽出は困難であった。よって、使用しているアルゴ
リズムには関係なく、その適用等の類似性のみでこれらの製品が承認されて上述の FDA
Database に掲載されている可能性があり、記載された数は ML 利用 SaMD の数を反映していない可能性に十分留意されたい。
また、2022 年、FDA は SaMD の審査を支援するため、いくつかのガイダンスを発行した。
一部の例を以下に示す。
4 月：医療機器のサイバーセキュリティに関するガイダンス草案第 2 版が発行された。このガイダンスでは、SaMD を含む医療機器におけるサイバーセキュリティに関する検討事項を示している [6]。
6 月：定量的放射線画像診断医療機器の市販前申請における技術的性能評価に関するガイ
ダンスが発行され、その設計、性能、ラベリング等、申請において検討すべき事項を示している [7]。
9 月：臨床診断支援ソフトウェアの該当性、並びに放射線画像診断医療機器の診断支援装置（Computer-Assisted Detection Device: CADe）の 510(k)による市販前申請に必要な臨床性能評価に関するガイダンスの改訂版が発行された。いずれも初版は 2012 年 7月に発行されている [8, 9]。また、同じ日にデータシステムや画像保存装置等の医療機器該当性に関するガイダンスも改訂発行されており、その初版発行は 2015 年 2 月であった [10]。

－ 5 －これら以外にも過去に公表されていた CADe やモバイルアプリ関連のガイダンスが次々と改訂・発行されている。しかしながら、大半は現状に即した微修正と“Medical Devices;
Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21stCentury Cures Act” に示された最終ルールを反映したのみとなっていることも当該文書に記載されていた。このことは、改訂版の内容に実質的な変更がないことを示しており、10 年
以上前の初版発行段階において既に ML 適用を想定した留意事項が示されていたことを示している。また、現在、問題となっている性能評価用データの使い回しに伴う懸念が明確に示されていると共に、その対応案についての例示が初版に既に記載されていた。一方、その内容に変更がないということは、この 10 年の研究でも性能評価用データの使い回しに伴い生じうるバイアスの軽減方法が見出されていないことを示唆しており、この問題についても更なる検討が必要であることが窺われた。
調査報告書（参考資料①）の 8 “MethodSense’s Experience in AI FDA Submission”では、SaMDの承認審査支援業務を経験した調査担当者が重要と感じた、申請者が審査において留意すべき点が紹介されている。
以下に、それらの事例を示す。
•

AI/ML 利用 SaMD の医療適用可否については、その領域に応じた審査チームがケー
スバイケースで判断するが、横断的な判断基準がない•

リスク管理に関する相互理解を深めるため、FDA が申請者に対して包括的なリスク管理に加えて使用者に起因したリスクアセスメントも提示することを求める•

AI に対する入力情報と出力される情報内容を考慮して、具体的な臨床的意義を徹底的に説明できることが重要となる•性能評価試験に用いるデータセットが意図する用途に対して科学的に妥当であり、且つ十分な数であることを示す必要がある•

AI/ML 利用 SaMD 及び当該 SaMD をインストール、あるいは操作する PC 等がサイ
バーセキュリティを確保していることが重要となる•

エンドユーザが正確な結果を得るために必要な入力情報を理解し、出力情報の妥当性が解釈できるよう適切なヒューマンファクターエンジニアリング（ユーザビリティ）を有する必要がある•

試験データは学習データと独立している必要があり、ファイヤーウォール等で保護して保管することが要求される•試験データが意図する用途を十分に反映したものでない場合には、FDA は申請された SaMD の適用をさらに限定した場合のみ承認する可能性がある•

設定した性能規格値については、妥当な臨床的、あるいは科学的意義を提供する必要がある•

性能に関しては、臨床使用において許容可能な範囲の再現性を有する根拠を提供する必要がある－ 6 －これらを踏まえて申請に必要な資料及び評価を FDA との事前相談ですり合わせることが、どの枠組みでの申請が適切かを判断し、迅速な審査と早期実用化のために極めて重要であることも示されている。上述した留意点は、本邦においても既に話題となっており、本研究事業も含め、その解決策に向けた様々な施策が進んでいる。よって、本邦の状況は必ずしも他国に劣るものではないと考えられる。
c) Pre-Cert の現状について2017 年より、繰り返しの設計・改良により性能のアップデートや不具合等への対応が可能となる SaMD に対して適切な規制枠組みを検討するために実施していた Pre-Cert については、前述のとおり総括文書に相当する “The Software Precertification (Pre-Cert) Pilot Program:
Tailored Total Product Lifecycle Approaches and Key Findings” [5] が 2022 年 9 月に FDA より公表された。総括に「この報告書をもって Pre-Cert の試行は一旦完了した」ことが明記されている一方、現在の規制下で Pre-Cert により提案された迅速な性能アップデートに資する各種アプローチを導入するには未だ課題が存在することも言及している。事実、Pre-Cert に参画する企業は 9 社が限界であり、検討可能であった SaMD、特に ML 利用 SaMD が限定的であったため幅広い製品を対象とした試験的検証が実施できなかったと共に、規制下で要求されていない情報を参画企業に要求することができなかったこと等の問題があったことが示されている。しかしながら、Pre-Cert により新たな規制コンセプトに対する理解を深めることができたこと、デジタルヘルス製品の設計・開発、管理における関係者の実践状況を理解することができたことを成果として示している。
このように一定の成果を上げたことを言及しているにもかかわらず、FDA は「Pre-Cert において提案した作業モデルで説明されていたアプローチを現在の規制枠組みで実施することは現実的でないと判断した」と結論づけ、新たな規制枠組みの必要性に言及している。今後は、2020 年に Center for Devices and Radiological Health（CDRH）に設立した The Digital
Health Center of Excellence を中心に、医療機器イノベーションコンソーシアムのような公的な他の組織と共同で政策とツールの開発を継続する方向であることが示されている。よって、報告書で示された結果は、中間報告的な位置づけとなり、今後、形を変えて Pre-Cert で提案した作業モデルを妥当な形に変更するための作業が進むことが予想される。このことは、5 年の時間を要しても、米国の薬事規制に Pre-Cert を導入することは容易ではなく、今後解決すべき課題が多数存在していることと共に、その検討を開始していない本邦を含む諸外国が同様の規制枠組みを導入することは極めて困難であることを示唆している。しかしながら、市販後学習による性能向上等、ML 利用 SaMD の実用化促進において、Pre-Cert
的な仕組みを導入する必要性はその実現可能性等も含め引き続き検討すべきと考える。
なお、The Digital Health Center of Excellence は前述した一部ガイダンスの改訂に携わっていることは把握できているが、現時点では本邦 PMDA におけるプログラム医療機器審査室のように審査実務を担当しているかは不明である。

－ 7 －2.3 欧州
2.3.1 背景
昨年度報告書で記載したように、欧州では AI に対する懸念をベースにした規制に係る各種取り組みを進めているものの、現時点でその法律は発効に至っていない。2024 年の完全施行を目指して EU の活動は続いており、産業界もその制定自体には同意しているとの報告がある。一方、違反時の制裁金が巨額になることや EU 内での活動制限が課されること、AIシステムや共用できないリスク等に関する定義については明確化が産学から要求されていること等から当該法律が開発規制に繋がることを懸念している様子も窺える [11, 12]。
一方、人工知能法の制定に先立って、認証機関による AI/ML 利用医療機器に関するガイ
ドライン策定が進んでいるとの報告もある。事実、ドイツの認証機関である TÜV-SÜD は
2021 年に白書を公表しており、安全性を確保するためのリスクベースの考え方、AI 技術と医療機器規制とのギャップを埋めるための考察、実際に AI 技術を医療機器に利用するための根本的クライテリア等の概略が記されている [13]。しかしながら、現時点では、欧州における規制当局と産業界との連携は米国よりも弱いと考えられる。調査報告書（参考資料①）に記載された欧州の現状を以下に整理する。
2.3.2 SaMD の開発・規制状況
今回の調査報告書では、2015 年から 2020 年の間に、AI/ML 利用 SaMD が 240 製品承認されていることが記されていた。一方、この内訳については明記しておらず、米国同様、ML
利用 SaMD の実数は不明である。
また、調査のベースとなった「European AI Startup Landscape」HP [14] を確認すると、ドイツ、スウェーデン、オランダ、ノルウェー、フランスには AI スタートアップ企業が非常に数多く存在することが分かるが、Human Health and Social Work Activities に分類される企
業数は 94 であった。実際にこれらの企業全てが AI/ML 利用 SaMD を開発しているかは未確認であるが、相応の数のスタートアップ企業が存在することが示唆されている。報告書には、注目企業として以下が紹介されている。
•

Evidencio：オランダに本社を構えるスタートアップ企業であり、臨床判断の裏付け用として CE 認証取得済み AI/ML 利用 SaMD を提供している•

Mediaire：ドイツのスタートアップ企業であり、定量的神経画像診断のために放射線科医や神経科医が活用できる AI ソフトウェア「mdbrain」を提供している。同社は容量解析、病変の特徴付け、動脈瘤の検知、ならびに腫瘍の特徴付けを行う AI ベースの支援製品を開発している。

•

IMAGEENS：フランスのスタートアップ企業であり、心血管画像診断データの活用
を通じて医師の臨床判断を支援する AI を提供している。

•

Nonpi Medical AB：スウェーデンのスタートアップ企業であり、AI による複雑な画像解析のためのグラフィカルユーザインタフェースである NICE Toolkit™の開発を手掛けている。

－ 8 －2.4 中国
参考資料①に記された、昨年度報告書以降の中国の動向は以下のとおりである。
規制当局である中国国家薬品監督管理局は以下のガイダンスを公表した。
•

Technical Review Guideline on Software Using Deep Learning Technology Assisted Decision
Making：ソフトウェアの技術要件のみに言及しており、規制要件には触れていない•

Guidelines for Compilation of Technical Requirements for Medical Device Products：メー
カ向けに、医療機器としての承認申請に必要な様式や項目を含んだ一般的要求事項が提供されている。

•

Guiding Principles for Registration and Review of Artificial Intelligence Medical Devices in
2022：先に公表されていた“Deep Learning Auxiliary Decision Review Key Point ofMedical Equipment Software”に代わる文書であり、ML 利用 SaMD による意思決定について詳細な説明が記載されていると共に、データソースを医療機器や汎用機器が新たに生成したデータにまで広げられている。

一方、産業界においては複数企業が AI/ML 利用医療機器の開発を進めていることが報告されており、具体的な注目企業として以下が挙げられている。
•

YITU Tech：肺がん、マンモグラフィー、乳腺超音波画像診断の AI/ML 利用製品を開発している。同社のシステムは、中国各地の 100 棟を超える病院で導入されている。

•

Wuhan Landing Intelligence Medical Co., Ltd：頸部癌スクリーニングと病理細胞分析の
AI/ML 利用製品を開発している。同社の製品は、中国の 400 を超える病院で導入さ
れている。

•

Huiying Medical Technology Co., Ltd：医療画像用のクラウド・プラットフォームと、
AI/ML 診断クラウド・プラットフォームを活用したビッグデータ分析ツールを開発している。同社の製品は、中国の 800 を超える病院で導入されている。

•

Infervision：AI/ML 医療プラットフォームを開発しており、X 線および CT 撮像支援
ならびに結核スクリーニングのための製品を提供している。これらの製品は、中国においては 25 の病院で導入されている。

•

Deepwise：AI/ML 支援型診断システムを開発しており、中国の 100 近い病院で利用されている。

•

VoxelCloud：肺がんの診断、眼底診断、冠動脈の CT スキャンのための AI/ML 利用製品を開発している。これらの製品は、中国の 100 を超える病院で利用されている。

•

Cable Wen Bo know Technology Co., Ltd：腫瘍科、血液内科、整形外科、神経科、呼吸器内科、精神科の分野を対象としたクラウド型カルテを開発している。

•

Unisound、SYNYI AI：それぞれ、AI を利用したカルテの音声／音入力システムに特化した企業である。

•

LinkDoc：臨床的意思決定を支援するための電子カルテシステムを開発している。現－ 9 －在、中国内の複数病院において同社の機器が試験的に運用されている。
2.5 韓国
参考資料①によると、現時点で、韓国における医療機器規制が変化した様子はないが、医療機器に提供可能な AI 技術開発を支援するガイダンスが追加発行されている。当該ガイダ
ンスの題名は“Using AI to Support Healthcare Decisions: A Guide for Society”であり、グローバ
ルガイド的な文書であることが窺える。作成者は、韓国科学技術院第四次産業革命政策セン
ター、シンガポール国立大学「リスクの公衆理解に資するロイズレジスター財団」及びイギ
リスを拠点とするサイエンスコミュニケーションのための非営利団体“Sense about Science”となっている。内容は、技術品質評価のための指針として AI 基礎データ、AI による患者や疾患に関する仮定、臨床時における AI 支援内容の影響度の 3 つを取り上げ、それらに対する問いを提供するものとなっている。
また、韓国食品医薬品安全局は、医療機器評価部直下にデジタルヘルス製品の管理、審査及び規制を支援する目的でデジタルヘルス機器部門を 2022 年 2 月 28 日に発足させた。具体的な目的は、AI や仮想現実（VR）を活用している製品の承認プロセスを加速することとなっている。
調査報告書によると、2021 年度の医薬品安全局発表に基づく韓国の AI 利用医療機器は
109 製品が承認されているが、調査報告リストではその後に確認できた製品、申請中の製品を含め 115 製品が記載されており、2022 年度には更にその数が増えていると予想される。
しかしながら、他国と同様、ML を利用した医療機器に特化した承認数は不明である。
現在、種々のスタートアップ企業が投資家からの着目を集めることに成功した結果、資金を調達しており、2022 年以降、AI/ML 利用医療関連製品の数はさらに増えることが予想されている。韓国における AI/ML 利用医療産業の現状については、韓国の技術革新情報を発信する企業 HP からも紹介されており、着目すべき企業として以下が紹介されている。

•

Standigm：新たな医薬品の発見を早めることを目標とし、医薬品の発見と開発に向けて AI 技術を活用する韓国の AI 系スタートアップ企業である。紹介された時点では、自社の AI プラットフォームを成長させる目的で$1500 万の資金を調達している。

•

Oncocross：癌治療薬の開発に特化し、既存の医薬品との新たな医療材料の適応性を確認するために AI を活用する韓国の AI バイオテック系スタートアップ企業である。
2022 年 2 月までに、Oncocross は開発の継続に向けて$1400 万を調達している。

•

3billion：D2C 型のスクリーニング検査という形で AI ベースの医療診断サービスを活用して希少・難治性疾患を診断する韓国の医療系スタートアップ企業であり、投資家から$1000 万を調達している。

•

AITRICS：病院で起こる敗血症や死亡に関連する緊急事態の発生を予測する製品
VitalCare を開発している。

•

AZothBio：新医薬品を開発するための AI バイオプラットフォームを開発しており、これまでに$5500 万を超える資金を調達している。

－ 10 －

2.6 ロシア
参考資料①によると、ユーラシア経済委員会により発行された法律により、医療機器に関する要件、基準、用語等が更新・変更されたため、医療機器の審査・登録への影響が生じることが予想されるものの、ロシア保健省は業界の要請を受けて 2023 年末までその施行を延期する方針となっている。
2022 年 9 月の段階では AI/ML 利用 SaMD が 22 製品、データベース“Roszavnadzor”に登録されていた。AI/ML 利用 SaMD は機器コードで分類されていることが判明しており、5 つのコードに該当する製品が確認されている。なお、他のコードで登録されている製品は確認できなかった。残念ながら、データベースより入手できる文書は英語への翻訳は困難な形式となっているため、それらの内容は調査企業でも把握することは不可能であった。
2.7 各国における AI を利用した SaMD の開発状況
インターテックジャパンから提供された参考資料②には、調査対象とした各国におけるAI/ML 利用 SaMD として上市、あるいは申請中の製品がリスト化されている。前述のとおり、全ての製品が ML を利用しているかは確認できないが、リストに掲載されていた製品数は以下のとおりである。
米国：359
欧州：89
中国：47
韓国：115ロシア：22
個々の製品の詳細については、参考資料②を確認されたい。

－ 11 －

3．国際標準化状況
現在、ML のデータ品質、AI システムのライフサイクルプロセス、機能安全及び AI シス
テム、AI システムの品質評価等を対象とした国際標準作成も進んでいるはずであるが、重要なプレイヤーであるロシアによるウクライナ侵攻以降、その進捗が把握できない。しかしながら、IEC/TC 62「医用電気機器」内に設立されているアドバイサリーグループである
Software Network and Artificial Intelligence advisory Group（SNAIG）は、AI 及びそれに関連する事項を取りまとめて今後の AI を利用した医療機器に関する策定指針を提示するため活動を継続しており、TC の内部レポートを発行していることが確認されている [15]。
SNAIG による当該報告書を確認したところ、今後作成する AI を利用した医療機器に関する標準は、基礎標準、機能標準、用途あるいは評価に特化した標準からなる三層構造とした
上でその製品化に利用することが提案されている。基礎標準としては、医療機器として要求される ISO 14971（リスクマネジメント）、ISO 13485（品質管理マネジメント）、IEC 62304（医療機器プログラムのライフサイクル）、IEC 62366-1（医療機器のユーザビリティエンジ
ニアリング）等が想定されると同時に、前述の標準を考慮して作成した AI の基礎となる要求事項を示した標準等が該当すると考えられる。一方、その他の 2 種類の標準に関しては、
現在利用できる標準は存在しないものの、国内標準として類似の文書が存在する国も存在する。そのため、今後 TC 62 で作成する標準については、それらとの整合性や三層構造を考慮した要求事項を付属書とすることを提案している。また、SNAIG は TC 62 のリエゾンである ISO/TC 215、TC 210 それぞれにデータマネジメントに関する標準作成、AI/ML 利用医療機器の特性を反映させた ISO 13485 の改正を要望している。
規制当局の対応としては、国際医療機器規制当局フォーラム（IMDRF）に AI に特化したワーキンググループ（WG）が設立され、関連した用語と定義に関する文書（IMDRF/AIMD
WG (PD1)/N67:2021 Machine Learning-enabled Medical Devices-A subset of Artificial Intelligenceenabled Medical Devices）を完成させた [16]。今後の方針についても議論が進んでおり、将来的な取り組みとして・Good Machine Learning Practice (GMLP)・Predetermined Change Control Plan（PCCP：事前変更計画）
・上記 2 件の議論で生じた課題解決
・データマネジメントを予定しており、ガイダンスの発行も検討することとなっている。

－ 12 －

4. 国内における開発及び薬事規制状況
4.1

SaMD の承認状況及び関連情報

2022 年度に SaMD として承認されたことが確認できた製品は以下のとおりである。
販売名（会社名）

承認年月

区別

承認／認証番号CureApp HT 高血圧治療補助アプリ

2022 年 4 月

新医療機器

30400BZX00100000

2022 年 6 月

改良（承認）

30400BZX00123000

2022 年 9 月

新医療機器

30400BZX00227000

2023 年 2 月

新医療機器

30500BZX00033000（株式会社 CureApp）
COVID-19 肺炎解析ソフトウェア SCOPA01（キヤノンメディカルシステムズ株式会社）
全静脈麻酔支援シリンジポンプ制御
ソフトウェア（日本光電工業株式会社）
サスメド Med CBT - i 不眠障害用アプリ（サスメド株式会社）

なお、深層学習を診断支援アルゴリズムに利用したアイリス株式会社の内視鏡テレスコ
ープ「nodoca（ノドカ）」（承認番号：30400BZX00101000）が 2022 年 4 月 26 日に新医療機器として承認されている。この製品は、公的保険に新機能・新技術（C2 区分）として収載された初の AI を利用した医療機器であることがアイリス株式会社の HP にて紹介されている [17]。また、2022 年度に新医療機器として承認された上記製品と nodoca については、
PMDA HP から審査報告書も公表されているため、SaMD 開発企業にとっては参考となる情報として活用できる状況となっている [18]。
現時点では、既存の 17 製品にML利用が確認されたキヤノンの製品を加えた計 18のML
利用SaMDが承認されていることになる。しかしながら、ML利用SaMDが認証品として市販されている可能性が否定できないだけでなく、付帯的な機能としてモダリティに付属して販売されている可能性があると共に、現時点でその調査方法がないため、結果として国内企業
が開発・販売している ML 利用 SaMD の実数は把握できていない。
規制改革推進会議においては、日本医療ベンチャー協会や日本デジタルヘルス・アライア
ンスが SaMD、特にデジタル治療製品における本邦の遅れを、仮登録で保険償還が可能であるドイツの DiGA 制度と比較して指摘している [19, 20]。ドイツの DiGA では、安全性と一定の有効性が確認できるデジタルヘルスアプリに対して 12 ヶ月の試用期間を設け最終的な有効性を示すためのリアルワールドデータを収集することが認められている。また、その間は開発企業が設定した償還価格で臨床使用可能となっている。対象となる SaMD の試用が可能となるためには、安全性と使用適合性を満たすことを示すため指定機関による CE マー
ク取得が要求されると共に、標準に適合したデータ保護や情報セキュリティの確保、品質及－ 13 －

びデータ総合運用性の確保が求められる。さらに、12 ヶ月の間に適切な指標に基づいたリ
アルワールドデータによる有効性の確認が認められると正式な承認を受けることとなり、以降は公的な保険償還の対象となる。
規制改革推進会議は 2022 年 12 月 22 日に ML 利用も含めた SaMD の早期承認を目的とした二段階承認制度の導入を目指す方針を「規制改革推進に関する中間答申」で以下のように示されている [21]。
（2022 年 12 月 22 日規制改革推進に関する中間答申）『SaMD はソフトウェアであり、その物理的性質上、人体に対する侵襲性が低いことが一般的である一方で、早期の臨床投入により性能の向上が加速する場合があること、ライ
フサイクルが他の医療機器よりも相当程度短期的であるといった特性を有するため、
SaMD の臨床現場における使用を早期に可能とする必要があることを踏まえ、SaMD に関する二段階承認制度を導入する方向（SaMD 版リバランス通知を新たに発出することにより対応する場合を含む。
）で検討する。その検討に当たっては、第一段階の承認については、非臨床試験で評価できる場合や探索的臨床試験が必要である場合の整理、標榜可能な臨床的意義の範囲など、プログラム医療機器の使用目的や機能等の違いに応じた検討を行う。な お、第二段階の承認に当たっては、治験による場合の他、リアルワールドデータなどを活用して有効性の確認を行いうることとする。
』
上記の中間答申を踏まえ、厚生労働省医薬・生活衛生局医療機器審査管理課は、令和 4 年度「プログラム医療機器の特性を踏まえた薬事承認制度の運用改善検討事業」（研究代表者：
中野壮陛（公益財団法人医療機器センター専務理事））を実施し、プログラム医療機器の特性に合った薬事承認制度の在り方を調査・検討し、議論の経過及び考え方の概要を含め、事業報告書として令和 4 年度中にとりまとめる予定である。事業報告書を踏まえ、令和 5 年度に二段階承認の方向性に関する通知を発出される見込みであり、二段階承認制度導入により承認に至るまでの期間を短縮することが期待される。
さらに、厚生労働省医薬生活衛生局医療機器審査管理課は、令和 4 年 9 月 2 日に通知「プログラム医療機器に係る優先的な審査等の試行的実施について」（薬生機審発 0902 第２号
厚生労働省医薬・生活衛生局医療機器審査管理課長通知）を発出し、プログラム医療機器の特性に合せた指定要件を設定し、期限を切って公募し、指定された品目は優先相談・優先審
査・事前評価・コンシェルジェ対応等を行い、目標総審査期間を 6 か月以内に短縮する取組みを開始した。この取組みは令和 5 年度も実績を踏まえて継続される見込みである。
また、治療用デジタルアプリに対するドイツの DiGA と同様の条件を SaMD に対して本邦で課す場合、その適合性をどこがどのように判断するのか明確にする必要がある。特に、CE マーキングに相当する部分については、担当機関に SaMD に関する相応の知識と経験が要求されるため、安全性確認が不十分になる可能性もあり、慎重な検討が必要と考えられる。
なお、ML 利用 SaMD の社会実装を図るため、厚生労働省はプログラム医療機器に関係す－ 14 －

る認証基準の拡充及び審査のポイント策定にも取り組んでおり、令和 4 年度は「呼吸装置治療支援プログラム」及び「放射線治療計画プログラム認証基準」の認証基準を新設した [22,23]。また、「腹膜透析用治療計画プログラム」、「歯科インプラント用治療計画支援プログラム」、「眼科手術用治療計画プログラム」の審査ポイントを公表した。令和 5 年度以降も認証基準の拡充及び審査のポイント策定は継続することが予想されるため、前述した二段階承認制度の導入と合わせた適切な運用で ML 利用 SaMD の社会実装が促進されることが期待される。
4.2 SaMD 産学官サブフォーラム 2023 を通じた薬事規制上の課題抽出と整理
厚生労働省の施策である DASH for SaMD の一環として、2023 年 2 月 6 日、ハイブリッド
方式で「SaMD 産学官サブフォーラム 2023 –プログラム医療機器における産学官連携 –」を開催した。当日の参加者は対面式 57 名（申込者 68 名：参加率 84%）
、Web 聴講 1,184 名（申込者 1,408 名：参加率 84%）であり、2022 年度も SaMD は非常に注目されていることが窺える。今回のサブフォーラムは、厚生労働省と経済産業省の共催となった第 2 回 SaMD
フォーラム（12/1、イイノホール）[24] において取り上げられた診療報酬制度の在り方、並
びに医療データの利活用について、さらに議論を掘り下げて課題等について産学官で共有し解決策を模索するための勉強会的な位置づけで、我々が事務局を担当して開催された。診
療報酬制度の在り方については、開発企業がビジネスモデルを考慮する上で非常に重要なテーマであったことから、参加者の多くが企業所属者になったと考えられる。しかしながら、診療報酬ベースのビジネスモデルは本邦の現在の財政状況を考慮すると非常に難しいことに加え、SaMD 販売による成功モデルが世界中を見渡しても稀であることから、従来とは異なる角度からビジネスモデルを検討する必要があることが総合討論でも言及された。もう一方のテーマである ML 利用 SaMD における医療データの利活用については、個人情報保護法の改正に伴って設けられた「仮名加工情報」の利用例やその問題点が話題になると共に、業界側からは性能評価試験におけるテストデータの信頼性確保の方法が未だ不明瞭なままである点が指摘された。また、前述した二段階承認制度を導入した場合に、最初の承認に必要な要件を明確にする必要があると共に、試行期間におけるリアルワールドデータ収集を容易とするための枠組みが必要であること等が言及された。また、実際の医療機関における情報提供のための仕組みの実情として、機関によっては情報提供窓口が一元化されていな
いと共に、一部データでは匿名化が困難であること等が紹介された。総合討論において、各々の課題に対する詳細な議論が為され、SaMD の実用化における一部の課題とそれらの解決に向けた問題点を参加者全員で共有することができたと思われる。
（発表内容についてはは参考資料③を参照のこと）。
サブフォーラム開催後のアンケートでは、対面式参加者 29 名（回答率 51%）
、Web 聴講者 540 名から回答が寄せられた（回答率 46%）
。第 1 回と同様 70%以上が企業からの参加者であり、講演及び総合討論内容についても好意的な意見が寄せられた。自由記述とした設問に対しても、第 1 回同様詳細な回答が寄せられており、SaMD に対する期待が大きいことが－ 15 －

窺える（詳細は参考資料④を参照のこと）。結果を見ると、製品化を目指して開発を進めているため、薬事上の要求事項やビジネスモデルと直結する保険点数に興味のある企業所属者の聴講が多かったと思われる。よって、関連省庁の各種施策の状況や今後の展開に関する産官学の連携、情報公開や討論が引き続き期待されていることが想像され、その解決の場として SaMD フォーラムを開催する意義は大きいと考えられる。

－ 16 －

5. まとめ
本事業は、厚生労働省による DASH for SaMD の連携施策として、海外諸国における AI/ML
利用 SaMD の規制実態や開発状況、関係する国際標準化状況、本邦の現状に関する調査を実施したものであり、その結果を本報告書に取りまとめた。また、施策の一環として開催する産官学連携フォーラムを補完する勉強会的な位置付けで開催した「SaMD 産学官サブフォ
ーラム 2023」での発表内容及び事後アンケート結果も整理して取りまとめた。
海外における実態調査の対象は米国が中心となったが、昨年度に引き続き欧州、中国、韓国、ロシアについても可能な範囲で調査を外部委託した。また、米国の状況については、弊部でもネット検索をベースにした調査を実施した。それらを合わせて検討した結果、以下が明らかとなった。
•

ML 利用 SaMD に特化した規制の迅速な導入を各国が争っているが、各種施策で先行している米国においても、当初期待された成果は得られておらず、承認審査等に新たな仕組みを導入できていない•「性能の可塑性」を最大の特徴とする ML 利用 SaMD の社会実装の可能性は調査対象の国々で検討されてはいるが、既存の医療機器規制ではその実現が困難であり、新たな枠組みの必要性が指摘されている•多少の相違はあるものの、現時点で各国のガイダンス等に記載されている要件や現在の規制実態は本邦と大きな差がないと共に、大きく先行している国はない•

本邦の PMDA に設立されたプログラム医療機器審査室と類似の組織を設けている国はあるが、その実態はいまだに明らかになっていない
特に、2022 年度に FDA により Pre-Cert の結果報告書が発行されたことは大きな動きであったものの、Pre-Cert の実装にあたっての課題が明確になると共に、その実装のためには更なる検討が必要との結論が示されていたのみであった。言い換えれば、着目していた米国でさえも新たな枠組みの導入に難渋しており、昨年度から大きく進捗した国は存在しないと思われる。FDA が Pre-Cert の追加検討を行う可能性があるため、その成り行きを見守る必
要はあるが、本邦において同様の仕組みを導入するのであれば、その実現可能性も含めた各
種検討を実施する新たな産学官連携プロジェクトを早急に進める必要がある。また、その際には国内におけるステークホルダーにとって実施可能な薬事枠組み、例えば変更計画確認申請制度（IDATEN）の活用促進に資する枠組みや日本版 GMLP の導入に関する可能性も検討すべきである。
経済産業省主導の第 2 回 SaMD フォーラム、並びに我々が事務局を担当した SaMD 産学官連携サブフォーラム 2023 の開催により、特に産業界が SaMD に対する保険償還とデータ利活用に大きな興味を有していることが判明した。企業が SaMD によるビジネスを進めるために重要であるため、前者に興味を示すのは当然であるが、サブフォーラムにおける討議やアンケート結果からは保険償還に頼ったビジネスしか想定していないため、SaMD や AI

－ 17 －

に対する保険点数が追加されないことへの行政への不満があることも示唆された。また、
SaMD 開発における後者の重要性についても、ようやく産学官における共通理解が熟成され、その課題解決を進めていく機運が高まってきている。しかしながら、そのためには個人情報保護法の適切な改正と運用が必要である。先の改正により、新たに仮名加工情報の枠組
みが設けられたものの、その収集段階から開発企業が関与する必要があるため、当該情報を収集する研究機関等と企業との連携をどのように構築・維持するかも課題となる。両者共に薬事では扱えない課題であるため、国策として AI を利用した SaMD の開発振興を進めるのであれば、トップダウンによる関係省庁の連携に基づいた施策構築が必須である。一方で、開発者となる企業・ベンチャーやその基盤技術を開発する研究機関等も AI を利用した
SaMD の迅速な社会実装を目指すのであれば、問題点・課題の指摘に留まらず、積極的な産学官連携の下、その解決に資する現実的な提案を構築する重要性が高まっていることを理
解されたい。そのための場として、SaMD フォーラムの枠組みは非常に有益であることが確認されたと思われる。よって、SaMD の迅速な社会実装に資する枠組みが整うまでは、その継続的な開催が求められる。
各国の開発状況においては、言語的な問題が大きく、調査対象国の正確な製品数を把握することは困難であった。2022 年度も結果的に米国の開発状況がクローズアップされているが、本邦においては「認証」として扱われる製品が大半となっており、Premarket Approval が必要な「承認品」の数では本邦における承認品数とかけ離れていない。本邦では ML 利用
SaMD が認証品として上市されている、あるいは承認品の附帯機能となっている可能性があり、その数を考慮しないままに他国の製品数との比較を実施することは公平性を欠いていると思われる。現状、上述した製品数の把握が困難であることも考慮すると、SaMD に対しては従来の医療機器とは別の薬事規制枠組みを構築することが必要になる可能性もある。
SaMD、特に ML 利用 SaMD の迅速な社会実装に貢献するためには、今回調査した内容を踏
まえ、薬事のみならず、行政全体に横串を刺した形で、開発も考慮した新たな規制枠組みを検討することが必要と考える。

－ 18 －

6. 参考文献等（Web リンクは 2023 年 2 月時点で確認済みのもの）[1] “Digital Health Innovation Action Plan” issued by CDRH, FDA, USA on August 1st, 2017.
(https://www.fda.gov/media/106331/download)[2] Discussion Paper and Request for Feedback “Propose Regulatory Framework for Modification
to Artificial Intelligence/Machine Learning (AI/ML) Based Software as a Medical Device(SaMD)”, issued by FDA, USA on April 2nd, 2019.
(https://www.fda.gov/files/medical%20devices/published/US-FDA-Artificial-Intelligence-andMachine-Learning-Discussion-Paper.pdf)[3] “Public Workshop – Evolving Role of Artificial Intelligence in Radiological Imaging” held at
Main Campus, NIH, Bethesda MD, USA on February 25th and 26th, 2020.
(https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/publicworkshop-evolving-role-artificial-intelligence-radiological-imaging-02252020-02262020)[4] “Artificial Intelligence and Machine Learning (AI/ML)-Based Software as a Medical Device
Action Plan” issued by The Digital Health Center of Excellence, CDRH, FDA, USA on
September 22nd, 2021.
(https://www.fda.gov/media/145022/download)[5] “The Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle
Approaches and Key Findings” issued by FDA, USA on September 26th, 2022.
(https://www.fda.gov/media/161815/download)[6] Draft Guidance for Industry and Food and Drug Administration Staff “Cybersecurity in Medical
Devices: Quality System Considerations and Content of Premarket Submissions” issued by
CDRH and CBER, FDA, USA on April 8th, 2022.
(https://www.fda.gov/media/119933/download)[7] Guidance for Industry and Food and Drug Administration Staff “Technical Performance
Assessment of Quantitative Imaging in Radiological Device Premarket Submissions” issued by
CDRH, FDA, USA on June 16th, 2022.
(https://www.fda.gov/media/123271/download)[8] Guidance for Industry and Food and Drug Administration Staff “Clinical Decision Support
Software” issued by CDRH, CBER, CDER, and Office of Combination Products in the Office of
the Commissioner, FDA, USA on September 28th, 2022.
(https://www.fda.gov/media/109618/download)[9] Guidance for Industry and Food and Drug Administration Staff “Computer-Assisted Detection
Devices Applied to Radiology Images and Radiology Device Data – Premarket Notification[510(k)] Submissions” issued by CDRH, FDA on September 28th, 2022.
(https://www.fda.gov/media/77642/download)[10] Guidance for Industry and Food and Drug Administration Staff “Medical Device Data Systems,
Medical Image Storage Devices, and Medical Image Communications Devices” issued by CDRH

－ 19 －

and CBER, FDA, USA on September 28th, 2022.
(https://www.fda.gov/media/88572/download)[11] 総務省 AI ネットワーク社会推進会議報告書用参考資料「人工知能に関する調和の取れたルールを定める規則の提案」概要(https://www.soumu.go.jp/main_content/000826707.pdf)[12] 総務省「AI ネットワーク社会推進会議」（第 21 回）AI ガバナンス検討会（第 17 回）
合同会議（令和 4 年 4 月 27 日開催）三部裕幸構成員発表資料(https://www.soumu.go.jp/main_content/000811790.pdf)[13] White Paper “Artificial Intelligence in Medical devices: Verifying and validating AI-based
medical devices” issued by TÜF-SÜD AG in 2021.
(https://www.tuvsud.com/en/resource-centre/white-papers/artificial-intelligence-in-medicaldevices より入手可能)[14] https://www.ai-startups-europe.eu/[15] International Electrotechnical Commission 62/432/INF “Forth report of the IEC TC 62 Advisory
Group SNAIG (Software Network and Artificial Intelligence advisory Group)” issued on
September 23rd, 2022 (Internal Document of IEC/TC 62).
[16] IMDRF Final Document (IMDRF/AIMD WG/N67) “Machine Learning-enabled Medical
Devices: Key Terms and Definitions” issued on May 6th, 2022.
(https://www.imdrf.org/documents/machine-learning-enabled-medical-devices-key-terms-anddefinitions)[17] https://nodoca.aillis.jp/[18] https://www.pmda.go.jp/files/000249403.pdf[19] 規制改革推進会議第 1 回医療・介護・感染症対策ワーキンググループ（2022 年 10 月 20日開催）
、資料 2-1：日本デジタルヘルス・アライアンス提出資料「プログラム医療機器（SaMD）の開発・実用化促進に向けた規制改革の方向性」(https://www8.cao.go.jp/kiseikaikaku/kisei/meeting/wg/2210_03medical/221020/medical01_0201.pdf)[20] 規制改革推進会議第 1 回医療・介護・感染症対策ワーキンググループ（2022 年 10 月 20日開催）
、資料 2-2：日本医療ベンチャー協会提出資料「SaMD 市場成長促進・環境整備のための提言」(https://www8.cao.go.jp/kiseikaikaku/kisei/meeting/wg/2210_03medical/221020/medical01_0202.pdf）[21] https://www8.cao.go.jp/kisei-kaikaku/kisei/meeting/committee/221222/agenda.html[22] https://www.mhlw.go.jp/content/11124500/001024855.pdf[23] https://www.mhlw.go.jp/content/11124500/001024856.pdf[24] https://dmd.nihs.go.jp/samd/index_20221201.html－ 20 －









!>D/




6)

,.B4

E

'$1

G -  2  0"FH5HVHDUFK 5HSRUW
3UHSDUHGIRU
-DSDQ1DWLRQDO,QVWLWXWHRI+HDOWK6FLHQFHV,VVXHGE\,QWHUWHN-DSDQ..

ຌϪϛʖφͺɼ ೧  ݆  ೖͶ఑ड़ࡃͲ͍Ζ௒ࠬϪϛʖφ -<5HY ΃͹ึଏࣆߴΝΉͳΌͪ΍͹Ͳͤɽ͞͹௒ࠬͺɼ0HWKRG6HQVH ऀ͹‫ྙڢ‬͹‫ݫ‬ɼࣰࢬ͢ͱ͕ΕΉͤɽ－ 21 －

Addendum to Artificial Intelligence in
Medical Devices 2021 Report
Prepared by:
MethodSense, Inc.
September 9, 2022

One Copley Pkwy, Suite 410
Morrisville, NC 27560(919) 313-3960© 2022 MethodSense, Inc.

－ 22 －

Disclaimer
The following addendum contains an assessment on behalf of Intertek Group plc (hereafterIntertek) and opinions from MethodSense, Inc. (hereafter MethodSense). MethodSense does not
accept or assume responsibility for any other purpose or to any other person to whom thisaddendum is shown or into whose hands it may come save other than those Intertek personnel
identified in the MethodSense proposal, which this addendum satisfies.
In preparing this addendum and documenting an evaluation and opinions, MethodSense hasrelied upon the information and documentation provided by Intertek and the references
identified in the References section of this report. MethodSense is not responsible for theaccuracy and completeness of the information shared with MethodSense by Intertek.
MethodSense will not accept responsibility to any other party other than Intertek to whom thisaddendum is addressed, unless specifically stated to the contrary by MethodSense in writing.
MethodSense will accept no responsibility for any reliance that may be placed on this addendum
should it be used for any purpose other than that for which it is prepared.
This addendum has been prepared with care and diligence and the statements and opinions in
the addendum are given in good faith and in the belief on reasonable grounds that suchstatements and opinions are not false or misleading. No responsibility arising in any way for errors
or omissions (including responsibility to any person for negligence) is assumed by MethodSenseor any of its partners or employees for the preparation of the addendum to the extent that such
errors or omissions result from MethodSense's reasonable reliance on information provided byIntertek or assumptions disclosed in the report or assumptions reasonably taken as implicit.
MethodSense reserves the right, but is under no obligation, to revise or amend this addendum if
any additional information (particularly as regards the assumptions MethodSense has reliedupon) which exists on the date of this addendum, but was not drawn to MethodSense’s attention
during its preparation, subsequently comes to light.

Confidential－ 23 －

Page 2 of 22

Table of Contents
1

Project Overview ..................................................................................................................... 4

2

Executive Summary ................................................................................................................. 4

3

Method of Research ................................................................................................................ 54

Important Definitions from International Medical Device Regulators Forum (IMDRF).......... 55

FDA Review Process ................................................................................................................ 7
5.1

Premarket Notification 510(k) Process ........................................................................... 8

5.2

De Novo Process .............................................................................................................. 8

5.3

Pre-Market Approval Process (PMA)............................................................................... 96

SaMD Submission Reviews ...................................................................................................... 9
6.1

FDA Product Codes for SaMDs ........................................................................................ 97

FDA Cleared AI Devices ......................................................................................................... 10

8

MethodSense’s Experience in AI FDA Submissions............................................................... 11
8.1

Indications for Use ......................................................................................................... 11

8.2

Risk Management .......................................................................................................... 12

8.3

Clinical Relevance .......................................................................................................... 12

8.4

Performance Testing ..................................................................................................... 12

8.5

Cybersecurity ................................................................................................................. 12

8.6

Human Factors .............................................................................................................. 12

8.7

Pre-Submission Meeting ............................................................................................... 13

9

AI Medical Devices in China .................................................................................................. 14

10

AI Medical Devices in Korea .................................................................................................. 15

11

AI Medical Devices in Russia ................................................................................................. 16

12

AI Medical Devices in the European Union ........................................................................... 17

13

References ............................................................................................................................. 18

Appendix A – Documents Reviewed ............................................................................................. 19

Confidential－ 24 －

Page 3 of 22

1

Project Overview

This addendum was requested by Intertek on behalf of the National Institute of Health Sciencesof Japan (NIHS). This addendum supplements the Intertek report, Artificial Intelligence in Medical
Devices 2021, to present an overview of the state of Artificial Intelligence in Medical Devices(AIMD) including software as a medical device (SaMD) and software in a medical device (SiMD).
The objectives of this addendum are to:
x
x
x
x
x
x

2

State Important Definitions from International Medical Device Regulators Forum (IMDRF).
Describe MethodSense’s experience in AI FDA submissions.
Describe the FDA review process for SaMD submissions.
Describe of the differences between the FDA review process for SaMD submissions andsubmissions that are not SaMDs, but include software as a component.
Describe the characteristics in FDA product codes or other product information publishedby the FDA that differentiates SaMDs and medical devices that include software as acomponent.
Indicate regulatory and market changes for AI products in Russia, China, Korea, and theEU.

Executive Summary

This addendum supplements the Intertek report, Artificial Intelligence in Medical Devices 2021.
Key points identified since the writing of the original report include the following:
x
x
x
x
x
x

x

FDA reviews all medical device submissions as either 510(k), de novo, or PMA, regardlessof the inclusion of software.
FDA considers every AI / ML product to be unique and recommends pre-submission
meetings for all new AI / ML devices.
FDA has shown specific interest in AI / ML devices’ indications for use, risk management
processes, clinical relevance, relevant performance testing, cybersecurity, and humanfactors testing.
Since the publication of the original report, the National Medical Products Administration(NMPA) in China has released 3 additional guidance documents for medical device
software.
The South Korean Ministry of Food and Drug Safety (MFDS) has established the Digital
Health Devices Division to manage, review, and offer regulatory support to digital healthproducts and has released one additional guidance related to AI in medical devices.
Decision #144 of the Eurasian Economic Commission (EEC) was officially implemented
throughout Eurasia on July 18th, 2022. However, the Russian Ministry of Health is not
currently requiring the implementation of Decision #144 from Russian manufacturers anddistributors.
The European Commission has identified a path of action for the Commission to achieveeffective implementation of AI in the healthcare sector with common legislation acrossthe EU.

Information about new products cleared in the US, EU, China, Korea, and Russia are provided in
the sections below.

Confidential－ 25 －

Page 4 of 22

3

Method of ResearchThis addendum utilized resources from the Intertek report, Artificial Intelligence in Medical
Devices 2021, dated May 2022. In compiling the information in this addendum and the attachedspreadsheet, numerous documents were reviewed. Such documents are listed in Section 12 AI
Medical Devices in the European Union
Since the publication of the Artificial Intelligence in Medical Devices 2021 report, published in May
2022, medical device legislation in the European Union has not changed. There is currently nocommon legislation specific to AI in the EU; however, Notified Bodies are actively working todevelop guidelines related to AI medical devices. In October 2021, the European Commission
published a study that identified a path of action for the Commission to achieve effective
implementation of AI in the healthcare sector with common legislation across the EU.
The European Commission published a draft law, the Artificial Intelligence Act (AIA), in April of2021. On May 4, 2022, a document “Final Report on Artificial Intelligence in the Digital Age” waspublished by the European Parliament that outlined a legal framework for regulation of AI
applications, products, and services, including in the health sector[12].
An analysis of AI/ML based medical devices in Europe identified that 240 AI/ML based medical
devices were approved in Europe between 2015 and 2020[13].
In early 2022, multiple organizations, funded by the German Entrepreneurship, German
Accelerator program, and Sweden’s Innovation Agency worked to develop a list of top AI startups
in Europe[14]. This provided a landscape to give companies guidance and drive adoption of AI
throughout Europe. Some of the highlighted medical device companies include:
x
x

x
x

Evidencio is a startup based in the Netherlands that offers CE-certified SaMDs for clinicaldecision support[15].
Mediaire, a startup based in Germany, offers AI software, mdbrain, for radiologists andneurologists to utilize for quantitative neuroimaging. This startup offers AI-based
solutions for volumetry, lesion characterization, aneurysm detection, as well as tumor
characterization[16].
IMAGEENS is a startup based in France that provides an AI that assists physicians in theirclinical decisions through the use of cardiovascular imaging data[17].
Nonpi Medical AB, a startup based in Sweden, developed NICE Toolkit™, a graphicalprogramming user interface for complex image analysis using AI[18].

References and Appendix A – Documents Reviewed.
The results of this evaluation are documented in this report.

4

Important Definitions from International Medical Device Regulators
Forum (IMDRF)

The International Medical Device Regulators Forum (IMDRF) is a voluntary group of diverse
medical device regulators with the intent to continue the work of the Global Harmonization Task
Force (GHTF) in order to support international medical device regulatory harmonization.
The following software related terms are identified by the IMDRF[1][2][3]:Confidential－ 26 －

Page 5 of 22

Term

Definition

Clinical Data

Safety, clinical performance and/or effectivenessinformation that is generated from the clinical use of a
medical device.

Clinical Evaluation

A set of ongoing activities that use scientifically soundmethods for the assessment and analysis of clinical data toverify the safety, clinical performance and/or effectivenessof the medical device when used as intended by the
manufacturer.

Clinical Evidence

The clinical data and its evaluation pertaining to a medical
device.

Clinical Investigation

Any systematic investigation or study in or on one or morehuman subjects, undertaken to assess the safety, clinicalperformance and/or effectiveness of a medical device.

Continuous Learning

Training that leads to change of an MLMD with eachexposure to data that takes place on an ongoing basis
during the operation phase of the MLMD life cycle.
(Modified from ISO/IEC DIS 22989)

Intended Use / Intended
PurposeThe objective intent of the manufacturer regarding the useof a product, process or service as reflected in thespecifications, instructions and information provided by the
manufacturer.

LOC

Level of Concern

Medical Device

Any instrument, apparatus, implement, machine,
appliance, implant, reagent for in vitro use, software,material or other similar or related article, intended by the
manufacturer to be used, alone or in combination, forhuman beings, for one or more of the specific medical
purpose(s) of:
x
x
x
x
x
x
x

diagnosis, prevention, monitoring, treatment or
alleviation of disease,diagnosis, monitoring, treatment, alleviation of, orcompensation for, an injury,
investigation, replacement, modification, or
support of the anatomy, or of a physiologicalprocess,
supporting or sustaining life,
control of conception,cleaning, disinfection or sterilization of medical
devices,
providing information by means of in vitro
examination of specimens derived from the humanbody;
Confidential－ 27 －

Page 6 of 22

Term

Definitionand does not achieve its primary intended action bypharmacological, immunological, or metabolic means, in oron the human body, but which may be assisted in its
intended function by such means.

MLMD

Machine Learning-enabled Medical Device

RL

Reinforcement learning

SaMD

Software as a Medical Device - Software intended to be
used for one or more medical purposes that perform these
purposes without being part of a hardware medical device.

SaMD Manufacturer“Manufacturer” means any natural or legal person5 withresponsibility for design and/or manufacture of a medical
device with the intention of making the medical device
available for use, under his name; whether or not such a
medical device is designed and/or manufactured by that
person himself or on his behalf by another person(s).

Semi-Supervised Machine
Learning

Machine learning algorithms that leverage both
unsupervised and supervised techniques during training.
(Modified from ISO/IEC DIS 22989)

Supervised Machine Learning

Machine learning that makes use of labelled data during
training. (ISO/IEC DIS 22989)

Test Dataset

A set of data that is never shown to the ML training
algorithm during training, that is used to estimate the MLmodel's performance after training.

Training

Process intended to establish or to improve the parametersof a ML model, based on an ML training algorithm, by using
training data. (Modified from ISO/IEC DIS 22989)

Training Dataset

A set of data that is used to train the ML model, which is
not part of the Test Dataset.

Unsupervised Machine
Learning

Machine learning that only makes use of unlabeled data
during training. (Modified from ISO/IEC DIS 22989)

Validation

Confirmation by examination and provision of objective
evidence that the particular requirements for a specificintended use can be consistently fulfilled

5

FDA Medical Device Submission Review Process

FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who
manufacture, repackage, relabel, or import medical devices sold in the United States. Medical
devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III.

Confidential－ 28 －

Page 7 of 22

Although the FDA device classification regulation defines the regulatory requirements for generaldevices, the classification regulation remains applicable to SaMDs.
This regulation describes that most Class I devices are exempt from Premarket Notification 510(k);most Class II devices require Premarket Notification 510(k); and most Class III devices require
Premarket Approval prior to placing the device in the market.
All manufacturers (including specification developers) of Class II and III devices, and select Class I
devices, are required to follow design controls (21 CFR 820.30) during device development. Whenplacing the device on the market, the manufacturer must comply with the full Quality System
Regulation requirements of 21 CFR 820, including post-market surveillance and reporting
requirements.
5.1

Premarket Notification 510(k) Process

The submitter of a 510(k) must demonstrate that the new device is “substantially equivalent” (SE)to a legally marketed (predicate) device in terms of intended use, safety, and effectiveness.
Substantial equivalence means that the new device is at least as safe and as effective as thepredicate. A device is substantially equivalent if, in comparison to a predicate, it has:xx

The same intended use as the predicate, and the same technological characteristics as
the predicate; or
The same intended use as the predicate, different technological characteristics, and theinformation submitted to FDA;o Does not raise new questions of safety and effectiveness; ando Demonstrates that the device is at least as safe and as effective as the legallymarketed device.

The published FDA review period for a 510(k) is 90 days. However, depending on the complexityof the device, quality of submission information, and questions the FDA may have during thereview of the submission, the overall time from submission to clearance may be longer. If the FDA
has questions, which will be detailed in an “additional information notice”, the review time is put
on hold and the submitter has 180 calendar days to respond.
5.2

De Novo Process

The de novo process provides a pathway to Class I or Class II classification for medical devices forwhich general controls or general and special controls provide a reasonable assurance of safety
and effectiveness, but for which there is no legally marketed predicate device.
There are two options for de novo classification for novel devices of low to moderate risk.
Option 1: Any person who receives a Not Substantially Equivalent (NSE) determination in
response to a 510(k) submission may, within 30 days of receipt of the NSE determination, submit
a de novo request for the FDA to make a risk-based evaluation for classification of the device into
Class I or II.
Option 2: Any person who determines there is no legally marketed device upon which to base adetermination of substantial equivalence may submit a de novo request for the FDA to make arisk-based classification of the device into Class I or II, without first submitting a 510(k) andreceiving an NSE determination.
The published FDA review period for a de novo is 120 calendar days. However, depending on thecomplexity of the device, quality of submission information, and questions the FDA may have
Confidential－ 29 －

Page 8 of 22

during the review of the submission, the overall time from submission to clearance may be longer.
If the FDA has questions, which will be detailed in an “additional information notice”, the review
time is put on hold and the submitter has 180 calendar days to respond. Devices that are classified
through the de novo process may be marketed and used as predicates for future 510(k)submissions.
5.3

Pre-Market Approval Process (PMA)

Pre-Market approval (PMA) is the FDA process of scientific and regulatory review to evaluate thesafety and effectiveness of Class III medical devices. The review of a pre-market approval
application is a five-step review process consisting of:
1. Administrative and limited scientific review by FDA staff to determine completeness(filing review);
2. In-depth scientific, regulatory, and Quality System review by appropriate FDA personnel;
3. Review and recommendation by the appropriate advisory committee (panel review);
4. Final deliberations, documentation and notification of the FDA decision; and5. A GMP audit of the manufacturer of the device and an inspection of the facility by the
FDA, which must be passed with no substantial findings, before final approval to market
the device will be authorized.

6

SaMD Submission Reviews

Although FDA has no major differences between SaMD submission reviews when compared toother device submission reviews, FDA has shown a strong preference toward Artificial Intelligence/ Machine Learning (AI / ML) devices or features being introduced to the agency via PreSubmission (Pre-Sub) Meetings prior to submissions.
A Pre-Sub includes a formal written request for FDA’s feedback. FDA provides such feedback in
the form of a formal written response and, optionally, a meeting. A Pre-Sub provides theopportunity to introduce FDA to the new AI / ML device and obtain FDA feedback prior to
submission. Pre-Sub requests include specific questions regarding review issues relevant to aplanned submission[4].
Although Pre-Subs are voluntary, early interaction with FDA, especially when introducing new AI/ ML devices or features, may improve the quality and speed of future submissions[4]. Pre-Subs
for AI / ML devices are further described in Section 8.7 Pre-Submission Meeting.
6.1

FDA Product Codes for SaMDs

MethodSense identified 40 product codes with indications which specify that they are intended
for software only devices. Of the 40 product codes that are intended for SaMDs, two (2) productcodes were classified as Class I, thirty-five (35) product codes were classified as Class II, and three(3) product codes were classified as Class III. The number of SaMD product codes under each 21
CFR Part varies, as shown in Table 1, with the most SaMD product codes regulated under 21 CFRPart 882 – Neurological Devices and 21 CFR Part 892 – Radiology Devices.

Confidential－ 30 －

Page 9 of 22

Table 1: Number of SaMD Product Codes per 21 CFR Part
21 CFR Part

Number of SaMD Product Codes

862 – Clinical Chemistry and Clinical Toxicology Devices

4864 – Hematology and Pathology Devices

2

868 – Anesthesiology Devices

2

870 – Cardiovascular Devices

5876 – Gastroenterology-Urology Devices

1878 – General and Plastic Surgery Devices

1880 – General Hospital and Personal Use Devices

1882 – Neurological Devices

10884 – Obstetrical and Gynecological Devices

1886 – Ophthalmic Devices

1888 – Orthopedic Devices

1892 – Radiology Devices

8

Total:37

7

FDA Cleared AI Devices

Since the publication of the Artificial Intelligence in Medical Devices 2021 report, published in May
2022, the following guidance documents have been released by FDA:xx

In April 2022, the draft guidance Cybersecurity in Medical Devices: Quality System
Considerations and Content of Premarket Submissions Draft Guidance for Industry andFood and Drug Administration Staff was revised to version 2 and published by FDA. The
guidance describes the security considerations of devices which contain software(including firmware) or are themselves SaMDs.
In June of 2022, the final guidance Technical Performance Assessment of Quantitative
Imaging in Radiological Device Premarket Submissions was published by FDA. The
guidance describes the design, performance, labeling, and submission considerations
specific for medical (quantitative) imaging devices for both devices which incorporate
software, or are themselves a SaMD.

Additionally, since the publication of the Artificial Intelligence in Medical Devices 2021 report,
published in May 2022, 109 additional AI / ML devices were identified as having been cleared by
FDA. Of the 359 total cleared AI / ML devices, 244 devices were cleared in the Radiology Division,
41 devices were cleared in the Cardiovascular Division, 13 devices each were each in the
Hematology Division and Neurology Division, and 48 devices were cleared in all other FDA
Divisions (see Figure 1).

Confidential－ 31 －

Page 10 of 22

Number of AI Devices Cleared

300
250

AI Medical Devices Cleared per FDA Division
244

200
150
100

0

48

41

50
Radiology

Cardiovascular

13

13

Hematology

Neurology

Other

FDA Division

Figure 1: AI Medical Devices Cleared per FDA Division

8

MethodSense’s Experience in AI FDA Submissions

MethodSense has supported several FDA submissions for 510(k) and de novo clearance of AIenabled products. Through supporting these submissions, the MethodSense team has learned
that FDA places specific focus on key areas when considering clearance / approval of AI-enabled
medical devices that differs slightly from other submissions (e.g. those focused on SaMD without
AI or SiMD). The areas we have encountered the most FDA feedback on an AI-enabled medical
device pre-market submission include the following inter-related topics:
8.1

Indications for Use

FDA places special emphasis on the indications for use and intended use of AI-enabled medical
devices, especially as it relates to the intended patient population and intended function (i.e.
treat, diagnose, inform, etc.). We have seen FDA significantly limit the indications for use of adevice due to insufficient data (e.g. clinical performance data was determined to be insufficient
for all claimed patient populations or insufficient to support use as a sole diagnostic). We haveadditionally seen FDA disagree with the identified Level of Concern (LOC) of the device and raise
the LOC (e.g. FDA believes a physician may rely on the information from the device and cause
serious injury or death for the patient), requiring additional evidence to support approval /clearance.
One important factor to consider in the indications for use is whether or not a device will beconsidered as an adjunctive device. MethodSense has found that the various FDA review groups
do not have a well-defined understanding of which AI-enabled medical devices can be consideredadjunctive and, as such, review each device on a case by case basis to determine if a device is truly
adjunctive.

Confidential－ 32 －

Page 11 of 22

8.2

Risk Management

FDA places great importance on the LOC for AI-enabled medical devices to ensure that thecompleted testing and additional evidence demonstrate appropriate safety and effectiveness ofthe device. As mentioned above, we have seen FDA disagree with the sponsor-defined LOC andrequire additional documentation and testing prior to clearance / approval.
Additionally, FDA’s agreeance or dis-agreeance on whether a device qualifies as adjunctive also
has a major impact on risk management activities.
The risk analysis for AI-enabled medical devices has been a common source of confusion for FDA
and we have seen similar questions across submissions where the risk management activities
were insufficient for FDA to understand how a device may be used in the clinical workflow andwhat clinical decisions may result from the output of the device. Recently, FDA has placed anemphasis the importance of submitting a User-Related Risk Assessment (URRA) in addition to an
all-encompassing Risk Assessment.
8.3

Clinical RelevanceThe clinical relevance of an AI-enabled medical device is an important factor in FDA’s review. With
the introduction of AI into medical devices comes the analysis of different kinds of data that may
or may not have well understood clinical relevance. It is important to thoroughly explain how thedata involved in an AI-enabled medical product is clinically relevant from an input and output
perspective.
8.4

Performance Testing

As part of proving safety and effectiveness of the device when used in accordance with its
intended use, FDA focuses heavily on clinical performance testing. For AI-enabled medical devices,performance validation involves clinical data to prove the clinical relevance and clinicalperformance of the product. FDA places heavy importance on the datasets used to ensure they
represent the intended uses of the device. If validation datasets do not adequately represent theintended uses (including patient populations, disease states, etc.), FDA may only clear the device
with limited indications. In terms of acceptable performance, FDA generally recommends the useof > 90% accuracy as the acceptable threshold. If this cannot be achieved, performance should be
proven to be equal to or, ideally, better than the current standard of care.
8.5

Cybersecurity

Since AI-enabled medical devices are software based, many utilize cloud infrastructures, andclinical data is assessed without always having oversight from a healthcare provider, cybersecurity
is more of a focus of FDA’s review. FDA expects that appropriate cybersecurity evaluation iscompleted, controls are implemented, and testing is performed to ensure safety andeffectiveness.
8.6

Human Factors

FDA typically expects a human factors evaluation of all AI-enabled medical devices to ensure thatthe end users are able to understand the necessary inputs to achieve accurate results andinterpret the relevance of the outputs. Since the end users do not have direct oversight on what
the algorithm is doing and only see the outputs, and since AI relies upon the inputs being correct,
it is important to ensure the end users are able to use the device and interpret the results.

Confidential－ 33 －

Page 12 of 22

8.7

Pre-Submission Meeting

As AI-enabled medical devices are relatively new and the regulatory framework governing thesedevices is ever-changing as new information comes to light, FDA recommends always having a
pre-submission for an AI-enabled medical device prior to the official premarket submission. This
pre-submission meeting can serve to build relations with the reviewers of the device and ensurethat key questions are answered early on, especially as they relate to the key areas mentioned
above. FDA encourages manufacturers to not consider feedback provided on one device relevant
for another as each product will be reviewed independently. It is also important to note that eachdepartment within FDA views AI-enabled medical devices slightly differently and regulate themdifferently. For example, certain departments will create an overarching product code that they
will regulate multiple AI-enabled products under, even if the definitions do not exactly match,allowing for a 510(k) submission in most cases. However, other departments will require a De
Novo submission when there are slight differences so that more unique product codes can becreated. Therefore, a pre-submission meeting is critical to ensure that there is understanding of
how FDA views the product prior to moving too far forward in the design, development, andtesting of the product.
Based on MethodSense’s experience during pre-submissions, 510(k)s, and De Novo submissions,the following include several important items to consider:x

As described in FDA’s Good Machine Learning Practice for Medical Device Development:
Guiding Principles, clinical data used to train an algorithm must be distinctly separate fromclinical data used to validate the algorithm. As part of implementing this, FDA has beenrequesting that a firewall must be used for the validation dataset proving that no
information of the validation data should be available before the algorithm is locked anddecision points are fixed.

xEnsure clinical relevance and performance is adequately communicated, a rationale
should be included to demonstrate the scientific validity and adequateness of any clinicaldata used to validate the algorithm to demonstrate that the data includes a sufficiently
representative sample of the device’s intended use conditions.

x

Ensure clinical relevance is adequately communicated, the “meaning” (e.g. clinical use,
context, etc.) of each output of the device, such as indices/scores, should be either clearly
described in labeling or known/obvious to the user.

x

Software requirement specifications should be sufficiently detailed and contain
information to demonstrate that the requirements are appropriate for the clinicalintended use. A rationale and data/evidence to support that the requirements areappropriate and sufficient should be provided.

x

A scientific rationale for why the chosen acceptance criteria and performance results areclinically acceptable should be provided. These acceptance criteria should be included in
product requirements / specifications where appropriate.

x

A rationale for the selected threshold / decision point(s) and why it is meaningful should
be provided. These acceptance criteria should be included in product specifications whereappropriate.

x

If data are removed or modified in any way from its original source in commercial use,
training, or validation of the algorithm, a detailed description and justification shall be

Confidential－ 34 －

Page 13 of 22

provided to confirm the algorithm is still clinically relevant for the intended clinical use
conditions.
x

9

As part of proving clinical performance, the repeatability and reproducibility of the device
when used as intended must be assessed and confirmed by providing evidence that thedevice has an acceptable level of reproducibility for clinical use.

AI Medical Devices in China

Since the publication of the Artificial Intelligence in Medical Devices 2021 report, published in May
2022, medical device legislation in China has not changed; however, the following guidance
documents have been released by the Chinese National Medical Products Administration (NMPA):xxx

In August of 2021, the Technical Review Guideline on Software Using Deep Learning
Technology Assisted Decision Making was released. The guideline is concerned only withthe technical requirements of software and does not consider legal and regulatory
requirements.
In February of 2022, the guidance document, Guidelines for Compilation of TechnicalRequirements for Medical Device Products, was published. The document provides
general requirements, including format and content, for the preparation of producttechnical requirements for registrants of medical devices in China.
Additionally, the Guiding Principles for Registration and Review of Artificial Intelligence
Medical Devices in 2022 was released to replace the NMPA Guidance: Deep Learning
Auxiliary Decision Review Key Point of Medical Equipment Software. The main differences
between the guidelines, as highlighted in Current Situation of Approval of Artificial
Intelligence Medical Device Registration Certification in China[5], are as follows:o The 2022 AI principles offer a more detailed explanation of decision-making andnon-auxiliary decision-making in AI medical device software.
o The 2022 principles have also broadened data sources from only medical device
data to include objective data generated from medical devices, objective data
generated from general-purpose equipment, and the generation and use of
medical device data.

AI-based medical devices are in rapid development by several Chinese companies. In the analysis
How AI Technology Enhances China Hospital Environment written in June of 2022[20], the following
companies were identified as making strides in the AI sector of healthcare in China.
x
x
x
x

YITU Tech has developed AI solutions in lung cancer, mammography, and breast
ultrasound imaging. Their system has been implemented in more than 100 hospitals
throughout China.
Wuhan Landing Intelligence Medical Co., Ltd develops AI solutions for automated neckcancer screening and pathologic cell analysis. Their products have been implemented in
more than 400 hospitals throughout China.
Huiying Medical Technology Co., Ltd develops medical image cloud platforms and big data
analysis tools using an AI diagnosis cloud platform. Their products have been
implemented in more than 800 hospitals throughout China
Infervision has developed an AI medical platform with solutions in X-ray and CT imaging
assistance as well as tuberculosis screening. These solutions are used in 25 hospitals in
China.
Confidential－ 35 －

Page 14 of 22

x
x
x
x
x

Deepwise has created an AI-Assisted Diagnosis system that is used in nearly 100 hospitals
throughout China.
VoxelCloud has developed AI solutions in lung cancer diagnosis, eye fundus diseases
inspection, and coronary CT scanning. These solutions are used in more than 100 hospitals
throughout China.
Cable Wen Bo know Technology Co., Ltd has developed a Cloud patient record for thefields of oncology, hematology, orthopedics, neurology, respiratory, and psychiatry.
Unisound and SYNYI AI are two companies that specialize in AI voice/sound input systems
for patient records.
LinkDoc has created an electronic patient record system to assist clinical decision making.
At the time of the article, their device was on trial in several hospitals.

One of the most common applications of AI in China’s healthcare industry is medical imaging. The
use of AI in medical imaging has been supported by the large volume of medical imaging data as
well as government policies that have been issued to increase support for domestic medical
imaging. Other areas of healthcare that have seen the presence of AI in China are diagnosis,
medicine discovery, health management, and disease prediction[19].

10 AI Medical Devices in Korea
Since the publication of the Artificial Intelligence in Medical Devices 2021 report, published in May
2022, medical device legislation in Korea has not changed; however, an additional guidance
document has been published to support the development of AI technology in medical devices.
This guidance document is a global guide titled, Using AI to Support Healthcare Decisions: A Guide
for Society. This document includes questions and answers regarding the usage of artificial
intelligence in healthcare. The guide was developed by the Korea Policy Center for the Fourth
Industrial Revolution at the Korea Advanced Institute of Science and Technology, the Lloyd’s
Register Foundation Institute for the Public Understanding of Risk at the National University ofSingapore, and the UK-based science communication non-profit Sense about Science. The guide
is intended to offer three guiding principles and questions to assess the quality of a technology,
which is based on the AI’s base data, the AI’s assumptions about patients and diseases, and how
influential the AI recommendation is in a clinical decision[6].
In addition to releasing guidance documents, in February 28th 2022, the South Korean Ministry ofFood and Drug Safety (MFDS) established the Digital Health Devices Division to manage, review,
and offer regulatory support to digital health products. The regulatory support offered by the
Digital Health Devices Division provides regulatory information and expedites the approval
process for companies commercializing software products utilizing AI and/or Virtual Reality (VR).
The Digital Health Devices Division is comparable to the U.S. Digital Health Unit, which specializes
in reviewing AI-based products[7]. The division was incorporated within the Medical Device
Evaluation Department of the National Institute of Food and Drug Safety Evaluation[8].
The 2021 Medical Device Approval Report published by the MFDS identified that approximately
109 AI medical devices have been approved in Korea. Although it has yet to be published, the2022 Medical Device Approval Report will be published with an update of the AI medical devices
that have been cleared in 2022.
The fast-paced creation of AI-based healthcare solutions is expected to be an upwards trend in
2022, and the following years, as startup companies raise funding. The article, Top Korean Medical
Confidential－ 36 －

Page 15 of 22

Startups Incorporating AI Technologies[9], offers insight into the growth of the AI-based healthcare
industry. Within the article, the following companies were highlighted as up-and-coming Korean
AI-based healthcare startups:
x

x
x
x
x
x

Standigm is a Korean AI startup that utilizes AI technology for drug discovery anddevelopment with the goal of expediting the discovery of new medicine. At the time thearticle was published in February 2022, Standigm had raised $15 million in funding for
growing their AI platform.
Oncocross, a Korean AI biotech startup, uses AI to confirm new medicine material
adaptability with existing medicines with a specialty in cancer drug development. By
February 2022, Oncocross had raised $14 million to continue development.
3billion is a Korean medical startup that diagnoses rare diseases using an AI-based medical
diagnostic service in the form of direct-to-consumer screening tests, and had attracted$10 million in investor funding.
AITRICS is developing a predictive solution, VitalCare, to predict the occurrent ofemergencies related to sepsis and mortality in hospitals.
AZothBio, the developer of an AI-Bio platform for the development of new drugs, hadraised over $5.5 million in funding.
Other startups have had similar success in attracting the attention of investors.

11 AI Medical Devices in Russia
Since the publication of the Artificial Intelligence in Medical Devices 2021 report, published in May
2022, medical device legislation in Russia has been updated with the implementation of Decision#144 of the Eurasian Economic Commission (EEC) and twenty-two (22) Devices/Systems havebeen listed on the Roszravnadzor: Federal Service for Surveillance in Healthcare database. Such
updates are further described in the below sections.
Decision #144 of the Eurasian Economic Commission (EEC) was officially implemented throughout
Eurasia on July 18th, 2022. This decision included requirement, criteria, and terminology updates,
among other changes, which affected medical device registration throughout Europe and Asia.
However, the Russian Ministry of Health, following requests from major manufacturers anddistributors, drafted a protocol for an extension to the execution of these registration changes
until December 31st, 2023. This amendment draft is to be presented for consideration at the next
EEC Council meeting. Thus, Russia is not currently requiring the implementation of Decision #144
from Russian manufacturers and distributors[4].
As of August 11th, 2022, twenty-two (22) Devices/Systems have been found on the Roszravnadzor:
Federal Service for Surveillance in Healthcare database[11]. These registered AI based medical
devices have been classified under the following device codes: 353180, 178120, 156770, 326360,
and 333160. Additional type codes have also been identified in accordance with the nomenclatureclassification of medical devices approved by the Ministry of Health of the Russian Federation;
however, as of the August 11th, 2022, there were no registered products classified under thesecodes. A summary of the device codes, number of devices registered under each code, and namecorresponding to each code can be found in Table 2, below.
For the twenty-two (22) registered devices, the certifications and related documentation included
within the registry were not available in a format to be translated to English with available
software tools.
Confidential－ 37 －

Page 16 of 22

Table 2: Roszravnadzor Medical Device Codes relating to AI

353180326360333160156770

Number ofRegisteredDevices12432178120127416027484032310000032952003358000363770036870003687100374740377700381940382750382980383580

0
0
0
0
0
0

38413038467000DeviceCode

Name
X-ray Image Interpretation Software
Software for interpreting the results of the IVD cancer risk assessment
Software for interpreting the results of human genomic analyses
Software for interpreting the results of the risk assessment ofcongenital anomalies/IVD syndromes
Software for interpreting the results of the risk/probability assessmentof cardiovascular diseases of IVD
Software for interpreting sleep disorders
Histology/Cytology/IIR Microbiology Image Interpretation Software
Software for interpreting osteoporosis/fracture risk assessment
results
Software for interpreting the results of identification of
microorganisms of IVD
Software for the interpretation of genetic markers of breast cancer
IVD
Software for interpreting the results of proteomic analyzes of human
IVD
Interpretive software for assessing the risk/probability ofcardiovascular disease IVD
Interpretive software to assess the risk/probability of cardiovasculardiseaseInfrared Thermographic System Interpreting Software
Software for the interpretation of dental X-rays
Software for the interpretation of dermatoscopic images
Software for the interpretation of neuropsychiatric disorder
Software for interpreting the results of human genomic analysis of IVD
Software for interpreting the results of human microbiome analyzes
of IVD
Software for interpreting the results of extracellular DNA IBD tests
Interpretive software for self-assessment of cancer risk

12 AI Medical Devices in the European Union
Since the publication of the Artificial Intelligence in Medical Devices 2021 report, published in May
2022, medical device legislation in the European Union has not changed. There is currently nocommon legislation specific to AI in the EU; however, Notified Bodies are actively working todevelop guidelines related to AI medical devices. In October 2021, the European Commission
published a study that identified a path of action for the Commission to achieve effective
implementation of AI in the healthcare sector with common legislation across the EU.
The European Commission published a draft law, the Artificial Intelligence Act (AIA), in April of2021. On May 4, 2022, a document “Final Report on Artificial Intelligence in the Digital Age” wasConfidential－ 38 －

Page 17 of 22

published by the European Parliament that outlined a legal framework for regulation of AI
applications, products, and services, including in the health sector[12].
An analysis of AI/ML based medical devices in Europe identified that 240 AI/ML based medical
devices were approved in Europe between 2015 and 2020[13].
In early 2022, multiple organizations, funded by the German Entrepreneurship, German
Accelerator program, and Sweden’s Innovation Agency worked to develop a list of top AI startups
in Europe[14]. This provided a landscape to give companies guidance and drive adoption of AI
throughout Europe. Some of the highlighted medical device companies include:
x
x

x
x

Evidencio is a startup based in the Netherlands that offers CE-certified SaMDs for clinicaldecision support[15].
Mediaire, a startup based in Germany, offers AI software, mdbrain, for radiologists andneurologists to utilize for quantitative neuroimaging. This startup offers AI-based
solutions for volumetry, lesion characterization, aneurysm detection, as well as tumor
characterization[16].
IMAGEENS is a startup based in France that provides an AI that assists physicians in theirclinical decisions through the use of cardiovascular imaging data[17].
Nonpi Medical AB, a startup based in Sweden, developed NICE Toolkit™, a graphicalprogramming user interface for complex image analysis using AI[18].

13 References
[1]
[2]
[3]
[4]
[5]

[6]

[7]

“Machine Learning-enabled Medical Devices: Key Terms and Definitions.” (2022,
May 09). Retrieved from IMDRF: https://www.imdrf.org/documents/machinelearning-enabled-medical-devices-key-terms-and-definitions“Clinical Evidence - Key Definitions and Concepts.” (2019, October 10). Retrieved
from IMDRF: https://www.imdrf.org/documents/clinical-evidence-key-definitionsand-concepts“Software as a Medical Device (SaMD): Key Definitions” (2013, September 18).
Retrieved from IMDRF: https://www.imdrf.org/documents/software-medicaldevice-samd-key-definitions“Requests for Feedback and Meetings for Medical Device Submissions: The QSubmission Program.” U.S. Food & Drug Administration, 6 Jan. 2021,
https://www.fda.gov/media/114034/download.
“Current Situation of Approval of Artificial Intelligence Medical Device Registration
Certificate in China.” Bradynuoen, Bradynuoen (Beijing) Pharm Tech Co., Ltd, 15 Apr.
2022, http://de.bradynuoen.com/news/current-situation-of-approval-of-artificialintelligence-medical-device-registration-certificate-in-china/.
Ang, Adam. “New Guide for AI Use in Healthcare Published in South Korea.”
Healthcare IT News, HIMSS Media, 16 Aug. 2021,
https://www.healthcareitnews.com/news/asia/new-guide-ai-use-healthcarepublished-south-korea.
Park, Gi-taek. “'Regulator to Clear 1st Digital Therapeutic Within This Year'.” Korea
Biomedical Review, Korea Biomedical Review, 29 Apr. 2022,
http://www.koreabiomed.com/news/articleView.html?idxno=13602&amp;utm_sou
rce=dable.
Confidential－ 39 －

Page 18 of 22

[8]

[9]
[10]

[11]
[12]

[13]

[14]
[15]
[16]
[17]
[18]
[19]
[20]

“National Institute of Food and Drug Safety Evaluation: Organization: ABOUT MFDS:
Minisry of Food and Drug Safety.” National Institute of Food and Drug Safety
Evaluation, Ministry of Food and Drug Safety,
https://www.mfds.go.kr/eng/wpge/m_48/de011033l002.do.
Yoon, John. “Top Korean Medical Startups Incorporating AI Technologies.” Seoulz,
Seoulz, 24 Feb. 2022, https://www.seoulz.com/top-korean-medical-startupsincorporating-ai-technologies/.
Mikhail Mylnikov, “The Procedure for National Registration of Medical Devices Can
Be Extended Until the End Of 2023,” 22 July 2022. [Online]. Available:
https://vademec.ru/news/2022/07/22/protseduru-natsregistratsii-medizdeliymogut-prodlit-do-kontsa-2023-goda/.
Roszdravnadzor, "Electronic Services," Federal Service for Surveillance in Healthcare.
Available: https://roszdravnadzor.gov.ru/services/misearch.
“EU Artificial Intelligence Act.” Center for AI and Digital Policy,
https://www.caidp.org/resources/eu-aiact/#:~:text=With%20the%20introduction%20of%20the%20Artificial%20Intelligence%20Act%2C,the%20higher%20the%20risk%2C%20the%20stricter%20the%20rule.
Muehlematter, Urs J, et al. “Approval of Artificial Intelligence and Machine Learning
Based Medical Devices in the USA and Europe (2015–20): a Comparative Analysis.”
The Lancet Digital Halth, Elsevier Inc., 18 Jan. 2021,
https://www.thelancet.com/action/showPdf?pii=S2589-7500%2820%2930292-2.
“Top AI Startups in Germany, Sweden, France and the Netherlands.” European AI
Startup Landscape, UnternehmerTUM, https://www.ai-startups-europe.eu/.
Evidencio. “Algorithm Library.” Evidencio,
https://www.evidencio.com/information#devices.
“Your Personal AI Assistant for Neuroimaging.” Mediaire,https://mediaire.de/en/home/.
“Home • Imageens.” Imageens, 16 June 2022, https://www.imageens.com/.
“Medical Image Analysis Made Easy.” MICE Toolkit, https://micetoolkit.com/.
Noël, Steffi. “AI in the Healthcare Sector in China: Current Trends and Applications.”
Daxue Consulting - Market Research China, 18 Nov. 2021,
https://daxueconsulting.com/ai-healthcare-china/.
“[Analysis] How AI Technology Enhances China Hospital Environment – June, 2020.”
Qualtech, 16 June 2020, https://www.qualtechs.com/de-de/article/424.

Appendix A – Documents Reviewed
MethodSense reviewed:
x
x
x
x
x
x
x

Kick-Off call with Mike Lynch
Emails, Communications, and Collaboration between Intertek and MethodSense
Draft Report 20220501 Artificial Intelligence in Medical Devices 2021.docx
FW_ [External] Updated Report and Product Database MLynch Email.pdf
FW_ [External] Updated Report and Product Database work left.pdf
Japan NIHS Assurance Report Project Scope.docx
Proposal for AI Product Update 2021.docx
Confidential－ 40 －

Page 19 of 22

x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x

Guideline for tech review MD Cybersecurity.docx
Guidelines for Software Review Second Edition.docx
imdrf-meet-190916-russia-yekaterinburg-12.pdf
Key Points CT-aided triage for pneumonia.docx
master_meng_xinyu_2019.pdf
Medtech AI & Software Regulation in China_ 5 Things to Know.pdf
New NMPA AI Guidelines.docx
NMPA Drafts Guideline of the Medical Device Software for Assistant to Decision-making
with Deep Learning Technique March, 2019.pdf
Review points and related instructions for deep learning-assisted decision-making
medical device software MDL.docx
Review points and related instructions for deep learning-assisted decision-making
medical device software.docx
Review points and related instructions for deep learning-assisted decision-making
medical device software.pdf
Rules for Classification of Medical Devices.pdf
t0120_AI_standardization_white_paper_EN.pdf(99+) China NMPA_ Guideline for classification and definition of AI medical software
products _ LinkedIn.pdf
21-6_RFQ-2_King_33-41.pdf
2020_AI-Healthcare-Report.pdf
Balzano_Written_Testimony_FINAL.pdf
China CMDE on AI Nov 2020.pdf
DEEPVESSEL FFR Receives NMPA Approval - Keya Medical.pdf
Guideline for classification of medical software products for AI.docx
Guideline for on-site inspection MD software and QMS.docx
Guideline for PTR.docx
edpb-edps_joint_opinion_ai_regulation_en.pdf
EESC-2021-02482-00-00-AC-TRA-EN.docx
Guideline for AI for medical products - GitHub Download.docx
IG-NB - Fragenkatalog Künstliche Intelligenz bei Medizinprodukten - Version 2.pdf
Impact Assessment Report 1 of 2.pdf
Impact Assessment Report 2 of 2.pdf
Impact Assessment Report Exec Summary.pdf
Medical Device AI - Overview 21-6_RFQ-2_Cobbaert_4-26.pdf
medtech-europe-response-to-the-open-public-consultation-on-the-proposal-for-anartificial-intelligence-act-6-august-2021-1.pdf
PIIS2589750020301126.pdf
Portolano.pdf
Team-NB-PositionPaper-Artificial-Intelligence.pdf
tuvsud-ai-in-medical-devices-whitepaper.pdf
21-8_Khambholja-2.pdf
2021-09-28-EU-Artificial-Intelligence-Act-The-European-Approach-to-AI.pdf
AIA Action Summary ST_13802_2021_REV_1_en.pdf
ai-guideline_Guideline-AI-Medical-Devices_EN.md at master · johner-institut_aiguideline · GitHub.pdf
Confidential－ 41 －

Page 20 of 22

x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x

ATI - Artificial Intelligence-based software as a medical device.pdf
bsi-md-de-qa-medical-webinar-samd-us-en.pdf
cellar_e0649735-a372-11eb-9585-01aa75ed71a1.0001.02_DOC_1.pdf
cellar_e0649735-a372-11eb-9585-01aa75ed71a1.0001.02_DOC_2.pdf
COCIR_Analysis_on_AI_in_medical_Device_Legislation_-_May_2021.pdf
easa_concept_paper_first_usable_guidance_for_level_1_machine_learning_applications_issue_01.pdf
diagnostics-12-00355.pdf
Guideline+on+Review+and+Approval+of+Digital+Therapeutics+(For+Industry).pdf
kjr-22-442.pdf
Korea Guideline for Approvel MD AI.pdf
Korea_National_Strategy_for_Artificial_Intelligence_2019.pdf
Use_of_Artificial_Intelligence-Based_Software_as_M.pdf
0063JKMS_jkms-35-e379.pdf
2019+Medical+Device+Approval+Repoert.pdf
2020+Medical+Device+Approval+Report.pdf
Draft Report 20220501 Artificial Intelligence in Medical Devices 2021 (2).docx
Interim Report - Artificial Intelligence in Medical Devices - 2021.docx
NIHS Proposal June 2021.pdf
Report - Artificial Intelligence in Medical Devices - 2021.docx
Report Example - Artificial Intelligence and Medical Devices.docx
Research & Report Estimate for Japan Natl Inst Health Science.xlsx
AI Software List March 2022.xlsx
Comparison of Interim Rev 0 and Interim Rev 2.docx
Draft Report 20220320 Artificial Intelligence in Medical Devices 2021.docx
radiation-01-00022.pdf
Regulation of artificial intelligence in healthcare in Russia.pdf
Russia New Medical Software Assessment Rules.pdf
Russian Methodical Recommendations for Medical Software Assessment _ RegDesk.pdf
RussiaRegulatoryProcessEMERGO1.pdf
1-s2.0-S0030438720300648-main.pdf
clinical_acceptance_of_software_based_on_artificial_intellegence_technologies__tVGt
4Pm.pdf
Emergo Summary of Docs for Russia and AI.pdf
imdrf-meet-190916-russia-yekaterinburg-04.pdf
On the rules for registering software as a medical device in Russia.pdf
Overview of Russian AI Products in Healthcare.pdf
Decree-of-the-President-of-the-Russian-Federation-on-the-Development-of-ArtificialIntelligence-in-the-Russian-Federation-.pdf
DOP-2020-U-027701-Final2.pdf
nocetti_russia_artificial_intelligence_2020.pdf
Russia-Artificial-Intelligence-Autonomy-Putin-Military.pdf
1-s2.0-S0030438720300648-main.pdf
B_0161_WRIGHT_ARTIFICIAL_INTELLIGENCE_CHINA_RUSSIA_AND_THE_GLOBAL_ORDE
R.pdf
NHSX_A_Buyers_Guide_to_AI_in_Health_and_Care.pdf
Confidential－ 42 －

Page 21 of 22

x
x
x
x
x
x
x
x
x
x

NHSX_AI_report.pdf
Software and AI as a Medical Device Change Programme - GOV.UK.pdf
The_roadmap_to_an_effective_AI_assurance_ecosystem.pdf
understanding_artificial_intelligence_ethics_and_safety.pdf
A guide to good practice for digital and data-driven health technologies - GOV.UK.pdf
AI_Council_AI_Roadmap.pdf
Chapter_10_Software_as_a_Medical_Device_PDF.pdf
Medical_device_stand-alone_software_including_apps.pdf
Medicines and Medical Devices Act 2021 Consultation Draft.pdf
National_AI_Strategy_-_PDF_version.pdf

MethodSense researched the following:
x

x
x
x

FDA databases and guidance documents to identify:o Differences between the FDA review process for SaMD submissions andsubmissions that are not SaMDs, but include software as a component.
o Characteristics in FDA product codes or other product information published by
the FDA that differentiates SaMDs and medical devices that include software as
a component.
o Additional AI devices that have been cleared since March 2022.
EUDAMED database
Updated reports located in the Intertek provided folders for each country of interest
General internet searches related to countries and devices of interest

Confidential－ 43 －

Page 22 of 22









!>D/




#&

C(<;A

G!>D/7D/H




95%

FDA AI/ML







Date of Decision

Clearance Summary

Product Name

Company Name Field

Product Code

Predicate

Source2021/6/17

K203514

Precise Position

Philips Healthcare
Radiology(Suzhou) Co., Ltd.

JAK

K180015

FDA Database of AI/ML

2021/6/16

K202718

Qmenta Care Platform
FamilyMint Labs, Inc.,
D/B/A. QMENTARadiology

LLZ

K142337

FDA Database of AI/ML

2021/6/11

K210484

LINQ II Insertable Cardiac
Monitor, Zelda AI ECGClassification System

Medtronic, Inc.

Cardiovascular

MXD

K200795

FDA Database of AI/ML

2021/6/10

K203629

IDx-DR

Digital Diagnostics
Ophthalmic
Inc.

PIB

DEN180001

FDA Database of AI/ML

2021/6/2

DEN200069

Cognoa Asd Diagnosis Aid Cognoa, Inc.

Neurology

QPF

n/a

FDA Database of AI/ML

2021/5/19

K210237

CINA CHEST

Avicenna.AI

Radiology

QAS

K190072

FDA Database of AI/ML

Radiology

KPS

K193241

FDA Database of AI/ML

2021/4/30

K210001

HYPER AiR

Shanghai United
Imaging
Healthcare
Co.,Ltd.

2021/4/23

K203502

MEDO-Thyroid

MEDO DX Pte.
Ltd.

Radiology

QIH

Kl91647

FDA Database of AI/ML

2021/4/23

K203314

Cartesion Prime (PCD1000A/3) V10.8

Canon Medical
Systems
Corporation

Radiology

KPS

K202349

FDA Database of AI/ML

2021/4/21

K210556

Preview Shoulder

Genesis SoftwareRadiology
Innovations

QIH

K182464)

FDA Database of AI/ML

2021/4/20

K203610

Automatic Anatomy
Recognition (AAR)

Quantitative
Radiology
Solutions, LLC

Radiology

QKB

Kl91928

FDA Database of AI/ML

2021/4/19

K203469

AI Segmentation

Varian Medical
Systems

Radiology

MUJ

Kl41248

FDA Database of AI/ML

2021/4/16

K203517

Saige-Q

DeepHealth, Inc.

Radiology

QFM

K183285

FDA Database of AI/ML

2021/4/14

K202992

BriefCase, RIB Fractures
Triage (RibFx)

Aidoc Medical,
Ltd.

Radiology

QFM

K190072

FDA Database of AI/ML

2021/4/9

DEN200055

GI Genius

Cosmo Artificial
Intelligence - AI,
Ltd.

Gastroenterolog
QNP
y-Urologyn/a

FDA Database of AI/ML

2021/4/2

K202441

Eclipse II with Smart Noise Carestream
Cancellation
Health, Inc.

Radiology

MQB

K180809

FDA Database of AI/ML

2021/4/1

DEN200038

Gili Pro Biosensor (Also
Known as Gili Biosensor
System)Cardiovascular

QOK

n/a

FDA Database of AI/ML

2021/3/31

K210071

SurgicalSIS System (Version 5.1.0) Information
Sciences, Inc.

Radiology

LLZ

K192304

FDA Database of AI/ML

2021/3/31

K203258

syngo.CT Lung CAD(Version VD20)

Siemens
Radiology
Healthcare GmbHOEB

K193216

Medical AI Evaluation

2021/3/31

K203443

MAGNETOM Vida,
MAGNETOM Sola,
MAGNETOM Lumina,
MAGNETOM Altea withsyngo MR XA31A

Siemens Medical
Solutions USA,
Inc.

LNH

K192924

FDA Database of AI/ML

2021/3/26

DEN200019

Oxehealth Vital Signs

Oxehealth Limited Cardiovascular

QME

n/a

FDA Database of AI/ML

2021/3/24

K203225

AquilionONE(TSXCanonMedical
306A/3)V10.4withSpectral SystemsImagingSystem
Corporation

JAK

K192828

FDA Database of AI/ML

Continuse
Biometrics Ltd.

Radiology

Radiology－ 45 －

2021/3/23

K210209

Viz ICH

Viz.Ai, Inc.

Radiology

QAS

K193658

FDA Database of AI/ML

2021/3/19

K203235

VBrainVysioneer Inc.

Radiology

QKB

K191928
K182624

FDA Database of AI/ML

2021/3/9

K203256

Imbio RV/LV Software

Imbio, LLC

Radiology

QIH

K111373

Medical AI Evaluation

2021/3/5

K202300

Optellum Virtual Nodule
Clinic, Optellum Software,
Optellum Platform

Optellum Ltd

Radiology

POK

DEN170022

FDA Database of AI/ML

2021/3/1

DEN200022

Analytic for Hemodynamic
Instability (AHI)

Fifth Eye Inc.

Cardiovascular

QNV

n/a

FDA Database of AI/ML

2021/2/25

K202990

NinesMeasure

Nines, Inc.

Radiology

LLZ

K162484

Medical AI Evaluation

2021/2/25

K203578

OTIS 2.1 Optical
Coherence Tomography
System, THiA Optical
Coherence Tomography
SystemPerimeter Medical General And
Imaging AI, Inc.
Plastic Surgery

NQQ

K190404

FDA Database of AI/ML

2021/2/19

K202212

TruplanCircleCardiovascular
Imaging Inc.

Radiology

LLZ

K153736

FDA Database of AI/ML

2021/2/9

K203103

Synapse 3D, Synapse 3D
Base Tools v6.1

Fujifilm
Corporation

Radiology

LLZ

K120361

FDA Database of AI/ML

2021/2/5

K210053

LVivo Software Application

DiA Imaging
Analysis Ltd.

Radiology

QIH

K200232

FDA Database of AI/ML

2021/2/1

K203518

Quicktome

Omniscient
Neurotechnology
Pty Ltd

Radiology

2021/1/29

K201411

Visage Breast Density

Visage Imaging
GmbH

Radiology

QIH

K180125

Medical AI Evaluation

2021/1/15

K193271

UAI Easytriage-Rib

Shanghai United
Imaging
Intelligence Co.,Ltd.

Radiology

QFM

K192901

Medical AI Evaluation

2021/1/14

K202700

ART-Plan

TheraPanacea

Radiology

QKB

K191928

FDA Database of AI/ML

Radiology

JAK

K170019
K192832

FDA Database of AI/ML

The Medical Futurist

2021/1/12

K201836

Aquilion Lightning (TSX036A/7) V10.2 With AiCE-I

Canon Medical
Systems
Corporation

2021/1/9

K200717

CLEWICU System(ClewICUserver and
ClewICUnitor)

Clew Medical Ltd. Cardiovascular

QNL

DEN160044,
K183646, K190205

FDA Database of AI/ML

2021/1/7

K202414

BrainInsightHyperfineResearch, Inc.

Radiology

LLZ

K170981

FDA Database of AI/ML

2020/12/29

K203508

BriefCase

Aidoc Medical,
Ltd.

Radiology

QAS

K190896

FDA Database of AI/ML

2020/12/22

K202229

AI Metrics

AI Metrics, LLC

Radiology

LLZ

K142647

FDA Database of AI/ML

2020/12/18

K201555

EchoGo Pro

Ultromics Ltd.

Radiology

POK

K190442

Medical AI Evaluation

2020/12/10

K201745

Deep Learning Image
Reconstruction For
Gemstone Spectral
Imaging

GE Medical
Systems, LLC

Radiology

JAK

K183202

FDA Database of AI/ML

2020/12/10

K203042

Aquilion Exceed LB (TSX202A/3) V10.6 With AiCE-I

Canon Medical
Systems
Corporation

Radiology

JAK

K192832, K150003

FDA Database of AI/ML

2020/12/7

K201039

HepaFat-AI

Resonance Health
Analysis Services Radiology
Pty Ltd.

LNH

K122035

FDA Database of AI/ML

2020/12/4

K202487

HealthJOINT

Zebra Medical
Vision Ltd.

Radiology

LLZ

K183544

FDA Database of AI/ML

2020/11/20

K200873

HALO

NICo-Lab B.V.

Radiology

QAS

DEN170073

Medical AI Evaluation－ 46 －

2020/11/20

K203169

Revolution Ascend

GE Healthcare
Radiology
Japan Corporation

JAK

K192686

FDA Database of AI/ML

2020/11/18

K201019

Genius AI Detection

Hologic, Inc.

Radiology

QDQ

K182373

FDA Database of AI/ML

2020/11/17

K193306

PROView

GE Medical
Systems SCS

Radiology

LLZ

K192200

FDA Database of AI/ML

2020/11/12

K193289

FastStroke, CT Perfusion
4D

GE Medical
Systems SCS

Radiology

JAK

K163281

FDA Database of AI/ML

2020/11/6

K200750

Neuro.Al Algorithm

TeraRecon, Inc.

Radiology

LLZ

K121916

Medical AI Evaluation

2020/11/6

K193562

Siemens Medical
AI-Rad Companion Organs
Solutions USA,
RT
Inc.

Radiology

QKB

K191928

FDA Database of AI/ML

2020/10/30

K200323

Autocontour

Radformation, Inc. Radiology

QKB

K130393|K181572

Medical AI Evaluation

2020/10/30

K202013

WRDensity by
Whiterabbit.ai

Whiterabbit.ai Inc. Radiology

QIH

K192973

Medical AI Evaluation

2020/10/28

K202089

Lenshooke X1 Pro Semen
Quality Analyzer,
Lenshooke X1 Pro Se
Semen Quality Analyzer

Bonraybio Co.,
Ltd.

POV

k180343

FDA Database of AI/ML

2020/10/16

K201710A View LCS

Coreline Soft Co.,
Radiology
Ltd.

LLZ

K162484|K043617|K1
Medical AI Evaluation
93220|K200714

2020/10/16

K200595

CellaVision DC-1,
CellaVision DC-1 PPACellaVision AB

Hematology

JOY

K092868

Medical AI Evaluation

2020/10/11

K202501

Quantib Prostate

Quantib BVRadiology

LLZ

K192200

FDA Database of AI/ML

2020/10/9

K193631

Stethee Pro 1, Stethee Pro M3DICINE Pty
Software System
Ltd.

Cardiovascular

DQD

K150272|K172296|K0
Medical AI Evaluation
83903

2020/10/2

K202280

Cleerly Labs V2.0

Cleerly, Inc.

Radiology

LLZ

K190868

Medical AI Evaluation

2020/10/2

K201301

X100 With Full Field
Peripheral Blood Smear(Pbs) Application

Scopio Labs Ltd.

Hematology

JOY

K092116

Medical AI Evaluation

2020/9/30

K192051

THINQ

CorticoMetrics
LLC

Radiology

LLZ

K170981

FDA Database of AI/ML

2020/9/25

K201103

Xeleris V Processing And
Review Systems

GE Healthcare

Radiology

LLZ

K191262|K153355|K1
Medical AI Evaluation
33649

2020/9/24

K200569

Raystation

Raysearch
Laboratories Ab(Publ)

Radiology

MUJ

K190387

Medical AI Evaluation

2020/9/18

K201992

Caption Guidance

Caption HealthRadiology

QJU

K200755

Medical AI Evaluation

2020/9/18

K200852

EchoPAC Software Only,
EchoPAC Plug-In

GE Medical
Systems
Ultrasound andPrimary Care
Diagnostics, LLC

Radiology

LLZ

K170847

FDA Database of AI/ML

2020/9/16

K201369

See-Mode
AVA (Augmented VascularTechnologies Pte. Radiology
Analysis)
Ltd.

LLZ

K170568|K122022|K1
Medical AI Evaluation
80647|K163253

2020/9/16

K201298

VX1

Cardiovascular

DQK

K093376|K093566|K1
Medical AI Evaluation
30626|K141185

2020/9/15

K192665

Accelerate Pheno System,
Accelerate
Accelerate Phenotest Bc
Diagnostics, Inc.
Kit

Microbiology

PRH

Volta Medical

Hematology－ 47 －

FDA Database of AI/ML

2020/9/9

K200708

Vivid iq

GE Medical
Systems
Ultrasound andPrimary Care
Diagnostics, LLC

Radiology

IYN

K200497|K181727|K1
81685|K160078|K191 Medical AI Evaluation
792

GE Medical
Systems
Ultrasound andPrimary Care
Diagnostics, LLC

Radiology

IYN

K200497|K181727|K1
81685|K160078|K191 Medical AI Evaluation
792|K181934

Cardiovascular

MLO

2020/9/9

K200851

Vivid T8, Vivid T92020/9/2

K200833

RX-1 Rhythm Express
Remote Cardiac Monitoring VivaQuant Inc.
System2020/8/26

K200714AVIEW

Coreline Soft Co.,
Radiology
Ltd.

LLZ

K183268|K043617|K1
93220|K171199|K990 Medical AI Evaluation
426|K141069

2020/8/26

K201020

BriefCase

Aidoc Medical,
Ltd.

Radiology

QAS

K190072

2020/8/14

K201632

Tomtec-Arena

Tomtec Imaging
Systems Gmbh

Radiology

LLZ

K200974|K191647|K1
Medical AI Evaluation
50122

2020/8/13

K201232

Limbus Contour

Limbus Ai Inc.

Radiology

LLZ

K173420

Medical AI Evaluation

2020/8/13

K201444syngo.via RT Image Suite

Siemens Medical
Solutions USA,
Inc.

Radiology

MUJ

K192065

Medical AI Evaluation

2020/8/7

K201310

Accipiolx

MaxQ Al Ltd.

Radiology

QAS

K182177

Medical AI Evaluation

2020/8/7

K200990

Vida|Vision

Vida Diagnostics
Inc.

Radiology

JAK

K083227

Medical AI Evaluation

2020/8/4

K193210

HYPER DLR

Shanghai United
Imaging
Healthcare Co.,Ltd.

Radiology

KPS

K172143|K182237

Medical AI Evaluation

2020/8/3

K200667

EyeArtEyenuk, Inc

Ophthalmic

PIB

DEN180001

Medical AI Evaluation

2020/7/30

K193283

AI-Rad Companion
Prostate MR

Siemens Medical
Radiology
Solutions USA Inc

QIH

K180336

Medical AI Evaluation

2020/7/30

K193417

FractureDetect (FX)

ImagenRadiology
Technologies, Inc.

QBS

DEN180005

Medical AI Evaluation

2020/7/23

K200743

Vivid E80/ Vivid E90/ Vivid
E95

GE Medical
Systems
Ultrasound andPrimary Care
Diagnostics, LLC

Radiology

IYN

K181685|K163077|K1
50087|K051449|K170 Medical AI Evaluation
823

2020/7/22

K200621

Caption Interpretation
Automated Ejection
Fraction Software

Caption HealthRadiology

QIH

K173780

Medical AI Evaluation

2020/7/16

K200905

HealthMammo

Zebra Medical
Vision Ltd.

Radiology

QFM

K183285

Medical AI Evaluation

GE Medical
Systems
Ultrasound andPrimary Care
Diagnostics, LLC

Radiology

IYN

FDA Database of AI/ML

Medical AI Evaluation

2020/7/16

K200497

Vivid S60N, Vivid S70N

2020/7/14

K193097

Vantage Orian 1.5T, MRTCanon Medical
1550, V6.0 With AiCE
Systems
Reconstruction Processing
Corporation
Unit For MR

Radiology

LNH

K193021|K192574

Medical AI Evaluation

2020/7/10

K192969

Ezra Plexo SoftwareRadiology

QIH

K173542

Medical AI Evaluation

2020/7/10

K193294

Siemens Medical
AI-Rad Companion Engine Solutions USA,
Inc.

Radiology

LLZ

Ezra AI Inc.

－ 48 －

FDA Database of AI/ML

FDA Database of AI/ML

2020/7/6

K193073

Deep Recon

Shanghai United
Imaging
Healthcare Co.,Ltd.

2020/7/2

K193252

Contour ProtégéAI

MIM Software,
Inc.

Radiology

QKB

K190379|K181572

Medical AI Evaluation

2020/7/2

K192880

InferRead Lung CT.AI

Beijing Infervision
Technology
Radiology
Co.,Ltd.

OEB

K161201

Medical AI Evaluation

2020/6/26

K200760

Rapid ASPECTS

ISchemaView Inc. Radiology

POK

DEN170022

Medical AI Evaluation

2020/6/24

K200855

CINA

AVICENNA.AI

Radiology

QAS

K180647|DEN170073 Medical AI Evaluation

2020/6/23

K200232

LVivo Software Application

DiA Imaging
Analysis Ltd

Radiology

QIH

K220000|K161382|K1
32544|K130779|K180 Medical AI Evaluation
995

2020/6/19

K193298

BriefCase

Aidoc Medical,
Ltd.

Radiology

QAS

K180647

Medical AI Evaluation

2020/6/17

K193290

AI-Rad Companion Brain
MR

Siemens Medical
Solutions USA,
Inc.

Radiology

LLZ

K182904

Medical AI Evaluation

2020/6/17

K200921

QER

Qure.Ai
Technologies

Radiology

QAS

K180647|K190896

Medical AI Evaluation

2020/6/11

K200980

Auto 3D Bladder Volume
Tool

Butterfly Network,
Radiology
Inc.

IYO

K172356

Medical AI Evaluation

2020/6/11

K200356

MEDO ARIA

MEDO.aiRadiology

QIH

K191647

Medical AI Evaluation
Medical AI Evaluation

Radiology

JAK

K183202|K172135

Medical AI Evaluation

2020/5/12

K192901

HealthVCF

Zebra Medical
Vision Ltd.

Radiology

QFM

K183285

2020/5/5

K193220AVIEW LCS

Coreline Soft Co.,
Radiology
Ltd

LLZ

K151283|K162484|K0
Medical AI Evaluation
43617|K171199

2020/5/5

K193176

uMR 780

Shanghai United
Imaging
Healthcare Co.,Ltd.

Radiology

LNH

2020/4/21

K193351

NinesAI

Nines, Inc.

Radiology

QAS

K180647

Medical AI Evaluation

2020/4/16

K200755

Caption Guidance

Caption Health,
Inc.

Radiology

QJU

DEN190040

Medical AI Evaluation

2020/4/13

K192167

CuraRad-ICH

CuraCloud Corp.

Radiology

QAS

K182177

Medical AI Evaluation

Radiology

LNH

K183231

Medical AI Evaluation

FDA Database of AI/ML

2020/4/10

K193282

Signa Premier

GE Healthcare(GE Medical
Systems, LLC)

2020/4/8

K193300

AIMI-Triage CXR PTX

RADLogics, Inc.

Radiology

QFM

K190362

Medical AI Evaluation

2020/3/31

K193087

Rapid ICH

ISchemaView
Incorporated

Radiology

QAS

K180647

Medical AI Evaluation

2020/3/26

K192732

Bodyguardian Remote
Monitoring System

Preventice
CardiovascularTechnologies, Inc.

DSIFDA Database of AI/ML

2020/3/26

K193518

KOSMOS

EchoNous, Inc.

Radiology

IYN

2020/3/25

K192854

MammoScreen

Therapixel

Radiology

QDQ

2020/3/25

K192437

Arterys MICA

Arterys Inc.

Radiology

QIH

2020/3/20

K193281

Hepatic VCARGE Medical
Systems SCS

Radiology

JAK

K110834|K081985|K0
Medical AI Evaluation
41521|K133649

2020/3/20

K200036

AI-ECG Tracker

Shenzhen
CarewellElectronics Co.,Ltd.

Cardiovascular

DPS

K113485|K062282

2020/3/18

K193658

Viz ICH

Viz.Ai, Inc.

Radiology

QAS

DEN170073|K180647 Medical AI Evaluation

2020/3/16

K193267

Al-Rad Companion(Musculoskeletal)

Siemens Medical
Solutions USA,
Inc.

Radiology

JAK

K123584|K183268|K1
Medical AI Evaluation
23585－ 49 －

FDA Database of AI/ML
K181704

Medical AI Evaluation
FDA Database of AI/ML

Medical AI Evaluation

2020/3/12

K192388

SonoVision UltrasoundImaging System

TissueDifferentiation
Intelligence, LLC

Radiology

IYN

2020/3/9

K193216

Syngo.CT Lung CAD

Siemens Medical
Solutions, Inc

Radiology

OEB

K191040|K143196|K1
Medical AI Evaluation
91309

2020/3/9

K192574

Vantage Galan 3T, MRTCanon Medical
3020, V6.0 With AiCE
Systems
Reconstruction Processing
Corporation
Unit For MR

Radiology

LNH

K181593|K181953

2020/3/5

K193229

Transpara

Screenpoint
Medical B.V.

Radiology

QDQ

DEN180005|K181704|
Medical AI Evaluation
K192287

FDA Database of AI/ML

Medical AI Evaluation

2020/3/4

K191550

Broncholab

Fluidda Inc.

Radiology

JAK

2020/2/28

K192962

icobrain-ctp

icometrix NVRadiology

LLZ

K121447|K180161

Medical AI Evaluation

FDA Database of AI/ML

2020/2/28

K191928

AccuContour

Xiamen Manteia
Technology Ltd.

Radiology

QKB

K182624

Medical AI Evaluation

Radiology

QFM

K190362

Medical AI Evaluation

2020/2/28

K191556

Red Dot

Behold.AI
Technologies
Limited2020/2/21

K192832

Aquilion Prime SP (TSX303B8) V10.2 with AiCE-I

Canon Medical
Systems
Corporation

Radiology

JAK

K172188|K183046

Medical AI Evaluation

2020/2/19

K192973

Densitas Densityai

Densitas, Inc.

Radiology

LLZ

K170540

Medical AI Evaluation

2020/2/14

K193248

Biograph Vision, Biograph
MCT Family Of PET/CTs

Siemens Medical
Solutions USA,
Inc.

Radiology

KPS

2020/2/13

K192828

Aquilion ONE (TSX-306A/3) Canon Medical
V10.0 With Spectral
Systems
Imaging System
Corporation

Radiology

JAK

2020/2/12

K193178

Biograph Horizon PET/CT

Siemens Medical
Radiology
Solution USA, Inc.

KPS

FDA Database of AI/ML

2020/2/10

K192377

Ethos Treatment
Management, Ethos
Treatment Planning, Ethos
Radiotherapy System,
HalcyonVarian Medical
Systems, Inc.

Radiology

IYE

FDA Database of AI/ML

2020/2/7

DEN190040

Caption Guidance

Bay Labs, Inc.

Radiology

QJU

Medical AI Evaluation

2020/1/24

K193109

MRCAT Brain

Philips Medical
Systems MR
Finland

Radiology

MUJ

2020/1/16

K192956

Auto Positioning

GE Hangwei
Medical Systems, Radiology
Co., Ltd.

JAK

2020/1/15

K192004

Eko Analysis Software

Eko Devices Inc

MWI

Cardiovascular

FDA Database of AI/ML

K163213|K192188|K1
Medical AI Evaluation
83046|K132813

K182888|K013644

Medical AI Evaluation

FDA Database of AI/ML
K151319|K182119|K1
80234|K073545|K131
Medical AI Evaluation
044|K170874|K17079
8

2020/1/15

K191125

ADAS 3D

Galgo Medical S.L Radiology

LLZ

FDA Database of AI/ML

2020/1/2

K183089

Air Next

NuvoAir AB

Anesthesiology

BZG

FDA Database of AI/ML

2019/12/20

K192383

BriefCase

Aidoc Medical,
Ltd.

Radiology

QAS

K180647|DEN170073 Medical AI Evaluation

2019/12/20

K191647

Qlab Advanced
Quantification Software

Philips Healthcare Radiology

QIH

K150122|K181264

2019/12/17

K192763

Syngo.CT CaScoring

Siemens Medical
Solutions USA,
Inc.

Radiology

JAK

2019/12/13

K193170

Deep Learning Image
Reconstruction

GE Healthcare
Radiology
Japan Corporation

JAK

2019/12/13

K192531

QyScore Software

QynapseRadiology

LLZ

FDA Database of AI/ML

NemoScanSoftware Nemotec
Radiology
S.L.

LLZ

FDA Database of AI/ML

2019/12/11

K192571－ 50 －

Medical AI Evaluation
FDA Database of AI/ML

K133640|K163213|K1
31576|K183202|K133 Medical AI Evaluation705

2019/12/10

K192287

Transpara

Screenpoint
Medical B.V.

Radiology

QDQ

DEN180005|K181704 Medical AI Evaluation

2019/12/9

K192442

FFRangio

CathWorks Ltd

Cardiovascular

QEK

FDA Database of AI/ML

2019/12/7

K192279

PhantomMSK Trauma

OrthoGrid
Systems Inc.

Radiology

LLZ

FDA Database of AI/ML

2019/11/27

K192945

7D Surgical System Cranial
Biopsy and Ventricular
7D Surgical Inc.
Catheter Placement
Application

Neurology

HAW

FDA Database of AI/ML

2019/11/26

K192320

HealthCXR

Zebra Medical
Vision Ltd.

Radiology

QFM

2019/11/25

K190529

SOZO

ImpediMed Limited

Gastroenterolog
QJB
y-Urology

2019/11/19

K191278

RSI-MRI+

Multimodal
Imaging Services
Radiology
Corporation (Dba
HealthLytix)

LLZ

K173744

Medical AI Evaluation

2019/11/13

K191171

EchoGo Core

Ultromics Ltd.

Radiology

QIH

K150122|K173780

Medical AI Evaluation

LLZ

K190362

Medical AI Evaluation
FDA Database of AI/ML

2019/11/7

K191026

MEDIP PROMEDICAL IP Co.,
Radiology
Ltd.

2019/11/5

K190868

Cleerly Labs

Cleerly Inc

Radiology

LLZ

K122429|K043111

Medical AI Evaluation

2019/11/5

K192109

Koala

IB Lab Gmbh

Radiology

LLZ

K172327|K172983

Medical AI Evaluation

2019/11/4

K190013

WellDoc BlueStar

WellDoc, Inc

General Hospital MRZ

FDA Database of AI/ML

2019/11/1

K190334MIMOSA Imager

MIMOSA
Diagnostics Inc.

MUD

FDA Database of AI/ML

Sight Diagnostics
Ltd.

General And
Plastic Surgery
Hematology

GKZ

FDA Database of AI/ML

FDA Database of AI/ML

2019/11/1

K190898

Sight OLO

2019/10/18

K183274

RTHawk, HeartVista
Cardiac Package

HeartVista, Inc.

Radiology

LNH

FDA Database of AI/ML

2019/10/17

K192455

Merge PACS

Merge Healthcare
Radiology
Incorporated

LLZ

FDA Database of AI/ML

2019/10/16

K191493

Ventripoint Medical System Ventripoint
Plus (VMS+) 3.0
Diagnostics Ltd.

Radiology

LLZ

FDA Database of AI/ML

2019/10/4

K191994

ProFound AI Software V2.1 ICAD Inc.

Radiology

QDQ

2019/10/4

K191713

CS-Series-FP
Radiographic /Fluoroscopic Systems With Omega Medical
Optional CA-100S /Imaging, LLC
FluoroShield¿ (ROI
Assembly)

Radiology

JAA

2019/9/18

K192065

Syngo.Via RT Image Suite

Siemens Medical
Solutions USA,
Inc.

Radiology

MUJ

K173635

Medical AI Evaluation

2019/9/16

K191688

SubtleMR

Subtle Medical
Inc.

Radiology

LLZ

K172768

Medical AI Evaluation

2019/9/13

K192304

SurgicalSIS Software Version 3.6.0 Information
Sciences, Inc.

Radiology

LLZ

K183019

Medical AI Evaluation

2019/9/11

K183370

PeraMobile and PeraWatch PeraHealth, Inc.

Cardiovascular

MWI

FDA Database of AI/ML

2019/9/11

K190815

Brainscope TBI

BrainScope
Company, Inc.

Neurology

PIW

FDA Database of AI/ML

2019/9/10

K183268

AI-Rad Companion(Cardiovascular)

Siemens Medical
Solutions USA,
Inc.

Radiology

JAK

2019/9/4

K191179

Myo Plus

Otto Bock
Healthcare
Products GmbH

Neurology

GXY

2019/8/29

K183489

D2P

3D Systems, Inc. Radiology

LLZ－ 51 －

K182373

Medical AI Evaluation

FDA Database of AI/ML

K113027|K123585|K9
Medical AI Evaluation
90426

FDA Database of AI/ML
K173619|K161841

Medical AI Evaluation

2019/8/29

K192107

Clarius Ultrasound Scanner

Clarius Mobile
Health Corp.

2019/8/15

K183282

Biovitals Analytics Engine

Biofourmis
Cardiovascular
Singapore Pte. Ltd

2019/8/15

K190925

HeartfFow FFRct Analysis HeartFlow, Inc.

2019/8/12

K183182

Critical Care Suite

GE Medical
Systems, LLC

2019/8/5

K191262

2019/7/26

Radiology

IYN

FDA Database of AI/MLPLB

FDA Database of AI/ML

Cardiovascular

PJA

FDA Database of AI/ML

Radiology

QFM

ABSI

EXINI Diagnostics
Radiology
AB

LLZ

K183271

AI-Rad Companion(Pulmonary)

Siemens Medical
Solutions USA,
Inc.

Radiology

JAK

2019/7/26

K182384

ACR | LAB Urine Analysis
Test System

Healthy.Io Ltd

ClinicalChemistryJFY

FDA Database of AI/ML

2019/7/19

K182798

KIDScore D3

Vitrolife A/SPBH

FDA Database of AI/ML

2019/7/12

K191585

INtuition-Structural Heart
ModuleObstetrics And
Gynecology

TeraRecon Inc.

Radiology

LLZ

FDA Database of AI/ML

2019/7/10

K182875

DeepCT

Deep01 Limited

Radiology

QAS

2019/7/10

K183322

PhysIQ Heart Rhythm andPhysIQ, Inc
Respiratory Module

CardiovascularDPS

FDA Database of AI/ML

2019/7/8

K191384

RayCare 2.3

RaySearch
Laboratories AB(Publ)

Radiology

MUJ

FDA Database of AI/ML

2019/7/5

K182901

Aquilion Precision (TSX304A/1 And /2) V8.8 With
AiCE

Canon Medical
Systems
Corporation

Radiology

JAK

FDA Database of AI/ML

2019/7/3

K190442

Koios DS For Breast

Koios Medical,
Inc.

Radiology

POK2019/7/1

K191272

Current Wearable Health
Monitoring System

Current HealthLtd.

2019/6/27

K190017

Livermultiscan (LMSv3)

Perspectum
Diagnostics Ltd

Hospitalmonitoring
Radiology

LNH

Ophthalmic

QER

K142897|K181444

Medical AI Evaluation

K190362

Medical AI Evaluation
FDA Database of AI/ML

K093621|K143196|K1
Medical AI Evaluation
23540

DEN170073|K180647 Medical AI Evaluation

K161959|DEN270022|
Medical AI Evaluation
DEN170022
The Medical Futurist
FDA Database of AI/ML

2019/6/25

K191194

CLARUSCarl Zeiss
Meditec, Inc

2019/6/19

K190387

Raystation

Raysearch
Laboratories Ab(Publ)

Radiology

MUJ

K180379

Medical AI Evaluation

2019/6/13

K183460

ClariCT AI

ClariPI Inc.

Radiology

LLZ

K160852

Medical AI Evaluation

2019/6/13

K190424

HealthichZebra Medical
Vision Ltd.

Radiology

QAS

K182177

Medical AI Evaluation

2019/6/12

K183046

Canon Medical
Aquilion ONE (TSX-305A/6)
Systems
V8.9 With AiCE
Corporation

Radiology

JAK

K170177

Medical AI Evaluation

2019/5/31

K190896

BriefCase

Aidoc Medical,
Ltd.

Radiology

QAS

K180647

Medical AI Evaluation

2019/5/24

K191083

COMPLETE CONTROL
System Gen2

Coapt, LLC

Neurology

GXY

FDA Database of AI/ML

K183646

Acumen Hypotension
Prediction Index - EV1000
Clinical Platform, Acumen
Hypotension Prediction
Index - Hemosphere
Advanced Monitoring
Platform, Acumen
Hypotension Prediction
Index, Hemosphere
Advanced Monitoring
Platform - Pressure

Edwards
Lifeciences, LLC

Cardiovascular

QAQ

FDA Database of AI/ML

2019/5/21－ 52 －

2019/5/15

K183648

2019/5/13

K190764

APAS Independence with
Urine Analysis Module

Microbiology

PPU

FDA Database of AI/ML

SurgicalAR

Clever Culture
Systems AG

MEDIVIS, Inc.

Radiology

LLZ

FDA Database of AI/ML

Radiology

QFM

2019/5/6

K190362

HealthPNX

Zebra Medical
Vision Ltd.

2019/5/1

K173681ReSET-O

Pear
Psychiatry
Therapeutics, Inc.

2019/4/22

K182513

FluChip-8G Influenza A+B
Assay

InDevR, Inc.

Microbiology

K183285

Medical AI Evaluation
The Medical Futurist

OZE

K172091|K150052|K1
Medical AI Evaluation
40079

2019/4/17

K181988

EMurmur ID

CSD Labs GmbH Cardiovascular

DQD

2019/4/15

K190072

Briefcase

Aidoc Medical,
Ltd.

Radiology

QAS

2019/4/12

K183202

Deep Learning Image
Reconstruction

GE Medical
Systems, LLC

Radiology

JAK

2019/4/8

K183204

Bone VCAR (BVCAR)Radiology

JAK

FDA Database of AI/ML

2019/3/29

K181352

Loop System

Spry Health, Inc.

Cardiovascular

DQA

FDA Database of AI/ML

2019/3/19

K183019

Radiology

LLZ

GE Medical
Systems SCS

FDA Database of AI/ML
K180647

Medical AI Evaluation
FDA Database of AI/ML

2019/3/11

K181823

SurgicalSIS Software Version 3.3.0 Information
Sciences, Inc.
KardiaAI
AliveCor, Inc.

Cardiovascular

DQK

2019/3/8

K183285

Cmtriage

Curemetrix, Inc

Radiology

QFM

2019/3/7

K182344

RhythmAnalytics

Biofourmis
Singapore Pte.
Ltd.

Cardiovascular

DQK

FDA Database of AI/ML

2019/2/16

K183704

Rx-1 Rhythm Express
Remote Cardiac Monitoring Vivaquant Inc.
SystemCardiovascular

DXH

FDA Database of AI/ML

2019/2/4

K181916

D-Nav System

Hygieia, Inc

General Hospital NDC

FDA Database of AI/ML

2019/2/1

K183272

AI Rad Companion(Engine)Siemens Medical
Solutions USA,
Inc.

Radiology

LLZ

FDA Database of AI/ML

2019/1/18

K183231

SIGNA Premier

GE Medical
Systems, LLC

Radiology

LNH

2019/1/17

K182456

Study Watch

Verily Life
Sciences Llc

Cardiovascular

DXH

FDA Database of AI/ML

Radiology

LLZ

FDA Database of AI/ML

Perspectum
Diagnostics Ltd

K162830|K173475

Medical AI Evaluation

DEN170073

Medical AI Evaluation

FDA Database of AI/ML

K171128

Medical AI Evaluation

2019/1/9

K183133

MRCP+ V1.0

2018/12/28

DEN170091

EyeBOX

Oculogica, Inc.

Neurology

QEA

FDA Database of AI/ML

Radiology

LLZ

FDA Database of AI/ML

2018/12/28

K180867

AmCAD-UO

AmCad BioMed
Corporation

2018/12/27

K182564

Quantib ND

Quantib BVRadiology

LLZ

2018/12/27

K182130

ISchemaView RAPID

ISchemaView, Inc. Radiology

LLZ

2018/12/21

K183012

VascuCAPLLZ

FDA Database of AI/ML

2018/12/20

K181861

Embrace

Elucid Bioimaging
Radiology
Inc.

Empatica Srl

Neurology

POS

FDA Database of AI/ML

2018/12/19

K182149

FFRangio System

CathWorks Ltd

Cardiovascular

QEK

FDA Database of AI/ML

2018/12/14

K182419

Centricity Universal Viewer GE Healthcare

Radiology

LLZ

FDA Database of AI/ML

2018/12/14

K182790

Cardio-TriTest v6.5

Cardio-Phoenix
Inc.

CardiovascularDPS

FDA Database of AI/ML

2018/12/6

K182373

PowerLook Tomo
Detection V2 Software

ICAD Inc.

Radiology

QDQ

2018/12/6

K173749

AMRA Profiler

AMRA Medical AB Radiology

LNH

2018/11/30

K182218

FerriSmart Analysis
SystemResonance Health
Analysis Service Radiology
Pty Ltd.

PCS

K124065|DEN130012|
Medical AI Evaluation
K043271

2018/11/30

K182336

SubtlePET

Subtle Medical,
Inc.

KPS

K063391

Radiology－ 53 －

K173939

Medical AI Evaluation
FDA Database of AI/ML

DEN180005

Medical AI Evaluation
FDA Database of AI/ML

Medical AI Evaluation

2018/11/29

K182181

Persyst 14 EEG Review
And Analysis Software

PersystDevelopment
Corporation

Neurology

OMB

2018/11/21

K181704

Transpara

Screenpoint
Medical Bv

Radiology

QDQ

2018/11/20

K181247

Vitrea CT Brain Perfusion

Vital Images, Inc.

Radiology

LLZ

2018/11/19

K180432

AI-ECG Platform

Shenzhen
CarewellElectronics., Ltd.

Cardiovascular

DQK

K052883|K113485

Medical AI Evaluation

2018/11/16

K180343

LensHooke X1 Pro Semen
Quality Analyzer,
Bonraybio Co.,
LensHooke X1 Semen
Ltd.
Quality Analyzer

Hematology

POV

K021746

Medical AI Evaluation

2018/11/6

K181939

icobrainRadiology

LLZ

K161148|K180326

Medical AI Evaluation

2018/11/2

K182616

NvisionVLE Imaging
System, NvisionVLE
NinePoint Medical, General And
Optical Probe, NvisionVLE Inc.
Plastic Surgery
Inflation System

NQQ

K153479

Medical AI Evaluation

2018/10/26

K182177

Accipiolx

MaxQ-Al Ltd.

Radiology

QAS

DEN170073|K180647 Medical AI Evaluation

2018/10/25

K181685

Vivid E80, Vivid E90, Vivid
E95

GE Medical
Systems
Ultrasound andPrimary Care
Diagnostics, LLC

Radiology

IYN

K173341|K082185

2018/10/17

K182034

Arterys MICA

Arterys Inc.

Radiology

LLZ

K173542|K171544|K1
Medical AI Evaluation
63253

2018/10/9

K181892

Ziostation2

Ziosoft, Inc.

Radiology

LLZ

FDA Database of AI/ML

Sense System with IBT
Electrodes

Infinite Biomedical
Technologies,
Neurology
LLC

GXY

FDA Database of AI/ML

2018/10/5

K182112

icometrix NV

FDA Database of AI/ML

DEN180005

Medical AI Evaluation
FDA Database of AI/ML

Medical AI Evaluation

2018/9/28

K173872

FibriCheck

Qompium NV

Cardiovascular

DXH

FDA Database of AI/ML

2018/9/28

K181771

RightEye Vision System

RightEye, LLC

Ophthalmic

GWN

FDA Database of AI/ML

2018/9/21

K182310Volpara Imaging Software

Volpara HealthTechnologies
LimitedRadiology

LLZ

FDA Database of AI/ML

2018/9/1

DEN180042

Irregular Rhythm
Notification Feature

Apple Inc.

Cardiology

2018/8/29

K181502

Zio AT ECG Monitoring
System, Zeus System

IRhythm
CardiovascularTechnologies, Inc.

2018/8/1

DEN180044

ECG App

Apple, Inc.

Cardiology

2018/8/1

K180647

BriefCase

Aidoc Medical,
Ltd.

2018/7/23

K173444

Quantitative Total
Extensible Imaging (QTxi)

2018/7/18

K173327

DIP/U.S. Urine Analysis
Test System

2018/7/10

K181572

Workflow Box

The Medical Futurist
DQK

K163512

Medical AI Evaluation

Radiology

QAS

DEN170073

Medical AI Evaluation

AIQ Solutions, Inc. Radiology

LLZ

FDA Database of AI/ML

Healthy.io Ltd

ClinicalChemistryJIL

FDA Database of AI/ML

Mirada Medical
Ltd.

Radiology

QKB

The Medical Futurist

K130393

Medical AI Evaluation

2018/7/10

K181574

Uscan

EchoNous, Inc.

Radiology

IYO

FDA Database of AI/ML

2018/6/29

K180038

NuVasive Pulse System

Orthopedic

OLO

FDA Database of AI/ML

2018/6/26

K173574

DenSeeMammo

NuVasive,
Incorporated
STATLIFE

Radiology

LLZ

FDA Database of AI/ML

2018/6/14

K173780

EchoMD AutomatedEjection Fraction Software

Bay Labs, Inc.

Radiology

LLZ

K130779

Medical AI Evaluation

2018/6/13

K172983

HealthCCS

Zebra Medical
Vision Ltd.

Radiology

JAK

K072737|K053347

Medical AI Evaluation

2018/6/12

DEN170043

DreaMed Advisor Pro

DreaMed
Diabetes, Ltd.

ClinicalChemistry

QCC

Medical AI Evaluation

2018/6/5

K173821

LungQ Software

Thirona
Corporation

Radiology

JAK

FDA Database of AI/ML－ 54 －

2018/5/25

K180163

TransEnterix Senhance
Surgical System

2018/5/24

DEN180005

OsteoDetect

2018/5/14
2018/5/14

TransEnterix, Inc

General And
Plastic Surgery

NAY

FDA Database of AI/ML

ImagenRadiology
Technologies, Inc.

QBS

Medical AI Evaluation

K173810Ventripoint Medical System Ventripoint
Plus (VMS+)
Diagnostics, Ltd.

Radiology

IYN

FDA Database of AI/ML

K180799

Clarius Ultrasound Scanner

Clarius Mobile
Health Corp.

Radiology

IYN

FDA Database of AI/ML

Radiology

IYN

FDA Database of AI/ML

2018/5/2

K180599

Venue

GE Medical
Systems
Ultrasound andPrimary Care
Diagnostics, LLC

2018/5/1

K162574

AmCAD-US

2018/5/1

K173931

MindMotion GO

AmCad BioMed
Corporation

2018/5/1

K172959

PeraServer and PeraTrend PeraHealth, Inc.

Cardiovascular

MWI

2018/4/20

K180161

Viz CTP

Viz.ai, Inc.

Radiology

LLZ

FDA Database of AI/ML

MindMaze SA

Radiology

The Medical Futurist

Orthopedics

The Medical Futurist
FDA Database of AI/ML
K121447

Medical AI Evaluation

2018/4/16

K180126

SOZO

Gastroenterolog
ImpediMed Limited
OBH
y-Urology

2018/4/11

DEN180001

IDx-DR

IDx, LLC

Ophthalmic

PIB

Medical AI Evaluation

2018/4/5

K180589

DR 800 With MUSICA
Dynamic

Agfa HealthCare
N.V.

Radiology

JAA

FDA Database of AI/ML

2018/4/1

K180455

NeuralBot

2018/3/16

DEN160044

2018/3/9

K173939

Radiology

Acumen Hypotension
Prediction Index (HPI)
Feature Software

Neural Analytics,
Inc.
Edwards
Lifesciences LLC

Cardiovascular

QAQ

FDA Database of AI/ML

Quantib Brain

Quantib BVRadiology

LLZ

FDA Database of AI/ML

Medic Vision Imaging Solutions Radiology
Ltd

LLZ

FDA Database of AI/ML

The Medical Futurist

2018/3/8

K173605

IQMR

2018/3/1

P160007

Guardian Connect System Medtronic

Endocrinology

2018/2/23

K170540

DM-Density

Densitas, Inc.

Radiology

LLZ

2018/2/13

DEN170073

ContaCT

Viz.Al, Inc.

Radiology

QAS

Medical AI Evaluation

2018/2/8

K180091

UNID Spine Analyzer

MedicreaInternational

Radiology

LLZ

FDA Database of AI/ML

2018/1/25

K173542

Arterys Oncology Dl

Arterys Inc.

Radiology

LLZ

2018/1/12

K173588

Illumeo System

Philips Medical
Systems
Radiology
Technologies, Ltd

LLZ

The Medical Futurist
K132742K101749|K163253

Medical AI Evaluation

Medical AI Evaluation

FDA Database of AI/ML

2018/1/11

K171122

CEREC Ortho Software

Dentsply Sirona

DentalPNN

FDA Database of AI/ML

2018/1/8

K171328

CNeuro CMRI

Combinostics Oy

Radiology

LLZ

FDA Database of AI/ML

2018/1/4

K171056

WAVE Clinical Platform

Excel Medical
Electronics, LLC

Cardiovascular

MWI

FDA Database of AI/ML

2017/12/27

K173420

Radiomics App V1.0

Microsoft Corp.

Radiology

LLZ

2017/12/22

K172507

SOZO

ImpediMed Limited Cardiovascular

2017/12/1

K172311

BioFlux

Biotricity Inc.

Cardiology

2017/11/7

K163694

Rooti Rx ECG Event
Recorder, Rooti Link APP
Software

Rooti Labs Ltd.

Cardiovascular

2017/10/27

K172803

Infinitt PACS 7.0

2017/10/20

K163623

QuantraInfinitt Healthcare
Radiology
Co.,Ltd.

Hologic, Inc.

K171936Peerbridge Cor(TM)SystemPeerbridge Health
CardiovascularInc.

2017/9/27
2017/9/15

K172356

BladderScan Prime PLUS
SystemVerathon
Incorporated

Radiology

Radiology－ 55 －

K103576

DSB

Medical AI Evaluation
FDA Database of AI/ML
The Medical Futurist

DRG

FDA Database of AI/ML

LLZ

FDA Database of AI/ML

LLZ

FDA Database of AI/MLDSH

FDA Database of AI/ML

IYO

K153101

Medical AI Evaluation

Clarius Mobile
Health Corp.

2017/9/14

K172385

Clarius Ultrasound System

2017/9/7

K170981

NeuroQuant

2017/8/17

K163339

SpectralMD DeepView
Wound Imaging System 2.0 SpectralMD, Inc.


2017/8/11

K172122

SOZO

2017/8/1

K171315

Advanced RBC Application Cella Vision AB

2017/7/19

DEN170022

QuantX

2017/6/26

K170568

CardioLogs ECG Analysis
Platform

2017/6/9

K170747

Siemens Medical
Syngo Application Software Solutions, USA,Inc.

CorTechs Labs,
Inc

ImpediMed Limited

Radiology

IYN

FDA Database of AI/ML

Radiology

LLZ

FDA Database of AI/ML

Cardiovascular

DPT

FDA Database of AI/ML

Gastroenterolog
OBH
y-Urology

FDA Database of AI/ML

Hematology

JOY

K033840|K092868

Quantitative
Insights, Inc

Radiology

POK

Medical AI Evaluation

Cardiologs
Technologies

CardiovascularDPS

FDA Database of AI/ML

Radiology

LLZ

K163285

Medical AI Evaluation

Medical AI Evaluation

2017/6/7

K170250

SmartTarget

SmarTarget, Ltd.

Radiology

LLZ

FDA Database of AI/ML

2017/5/24

K170172

UNiD Spine Analyzer

MedicreaInternational

Radiology

LLZ

FDA Database of AI/ML

2017/5/11

K163622

Lung Vision

Radiology

LLZ

FDA Database of AI/ML

Anesthesiology

MNR

FDA Database of AI/ML

Body Vision
Medical Ltd.

Zephyr Sleep
Technologies

2017/5/5

K163665

MATRx Plus

2017/4/26

K170069

AmCAD-UV

AmCad BioMed
Corporation

Radiology

LLZ

FDA Database of AI/ML

DEN160026

23andMe Personal
Genome Service (PGS)
Genetic Health Risk Test
for Hereditary
Thrombophilia

23andMe, Inc.

Hematology

PTA

FDA Database of AI/ML

2017/4/6

2017/3/31

K162627

EnsoSleep

EnsoData, Inc.

Neurology

OLZ

FDA Database of AI/ML

2017/2/23

K162855

Reveal LINQ

Medtronic, Inc.

Cardiovascular

MXD

FDA Database of AI/ML

2017/2/14

K162830

SIS Software

SurgicalInformation
Sciences, Inc.

Radiology

LLZ

K050438|K140828|K0
Medical AI Evaluation
81512

2017/1/6

K163013

Quantib Brain 1.2

Quantib BVRadiology

LLZ

FDA Database of AI/ML

2017/1/5

K163253

Arterys Cardio DL

Arterys Inc.

Radiology

LLZ

FDA Database of AI/ML

Neurology

Radiology

LLZ

2017/1/1

K161328

Cantab Mobile

CAMBRIDGE
COGNITION
LTD.

2016/12/28

K161959

ClearView CCAD

ClearView
Diagnostics Inc.

The Medical Futurist

K050846

Medical AI Evaluation

2016/12/7

K161322

CT CoPilot

Zepmed, LLC

Radiology

LLZ

FDA Database of AI/ML

2016/11/30

K161834

One Drop Blood Glucose
Monitoring System

AgaMatrix Inc.

ClinicalChemistryNBW

FDA Database of AI/ML

2016/11/30

K163138

Clarius Ultrasound System

Radiology

IYN

FDA Database of AI/ML

Radiology

MYN

FDA Database of AI/ML

Clarius Mobile
Health Corp.

QView Medical,
Inc.

2016/11/9

P150043

QVCAD System

2016/10/19

K160401

Tyto Stethoscope

Tyto Care Ltd.

Cardiovascular

DQD

FDA Database of AI/ML

2016/9/22

K161068

Ahead 300

Neurology

PIW

FDA Database of AI/ML

2016/9/19

K161625

PixelShine

Brainscope
Company Inc.

AlgoMedica

Radiology

LLZ

FDA Database of AI/ML

Radiology

OEB
LLZ

2016/9/9

K161201

ClearRead CT

RiverainTechnologies,
LLC

2016/8/9

K161148

Icobrain

Icometrix

Radiology

Gauss Surgical
Inc.

General And
Plastic Surgery

2016/8/5

K160338

Triton System

2016/7/28

K161382

LVivo Software Application DiACardio, Ltd.

2016/7/15

K160016

Steth IO

2016/7/7

K160088

Cydar EV

Stratoscientific,
Inc.

Cydar Ltd.

K092363|K143196|K0
Medical AI Evaluation
93621
FDA Database of AI/MLPBZ

FDA Database of AI/ML

Radiology

LLZ

FDA Database of AI/ML

Cardiovascular

DQD

FDA Database of AI/ML

Radiology

OWB

FDA Database of AI/ML

LLZ

2016/6/17

K153351

Quantib Brain 1

Quantib BVRadiology

2016/3/1

K143468

QbCheck

QbTech AB

Psychiatry－ 56 －

FDA Database of AI/ML
The Medical Futurist

2016/1/7

K153427

Volpara Imaging Software

2015/12/21

K150817

Dario Blood Glucose
Monitoring System

2015/11/5

K150102

SnoreSounds

2015/6/11

K142512

Personalized Physiology
Analytics Engine Software

Matakina
Technology Ltd.

Radiology

LLZ

FDA Database of AI/ML

ClinicalChemistryNBW

FDA Database of AI/ML

Anesthesiology

MNR

FDA Database of AI/ML

VGBio, Inc. (DBA
Cardiovascular
PhysIQ)PLB

FDA Database of AI/ML

General Hospital NDC

FDA Database of AI/ML

Ophthalmic

FDA Database of AI/ML

LabStyle
Innovations Ltd.

Appian Medical
Inc.

Monarch Medical
Technologies

2015/4/24

K142918

EndoTool SubQ

2015/2/27

K141922

IRIS Intelligent Retinal
Imaging System

IRIS Intelligent
Retinal Imaging
Systems, LLC

2014/11/17

DEN140025

BrainScope Ahead 100

Neurology

PIW

FDA Database of AI/ML

2014/10/10

K142037

QuantraBrainScope
Company, Inc.

Hologic, Inc.

Radiology

LLZ

FDA Database of AI/ML

2014/9/17

K141069

Lung Density Analysis

Imbio LLC

Radiology

JAK

FDA Database of AI/ML

Radiology

LLZ

FDA Database of AI/ML

NFJ

2014/8/22

K141480

CVI42

CircleCardiovascular
Imaging Inc

2014/8/1

K140933

AliveCor

AliveCor

Cardiology

Hepatic VCARGE Medical
Systems SCS

Radiology

JAK

FDA Database of AI/ML

Radiology

KPR

FDA Database of AI/ML

2014/4/22

K133649

The Medical Futurist

2014/1/24

K133259

Ysio Max

Siemens Medical
Solutions USA,Inc.

2013/11/21

K130831

FDA Database of AI/ML

DEN130013

Vitek MS

Bruker Daltonics,
Microbiology
Inc.

PEX

2013/8/21

MALDI Biotyper CA (MBTCA) System

Biomerieux, Inc.

Microbiology

PEX

FDA Database of AI/ML

2013/3/22

K120771

UniCel DxH 800 Coulter
Cellular Analysis System

Beckman Coulter,
Hematology
Inc.

GKZ

FDA Database of AI/ML

LLZ

FDA Database of AI/ML

RiverainTechnologies

Radiology

Preventice

Cardiology

Pathwork
Diagnostics, Inc.

Pathology

OIW

FDA Database of AI/ML

RadLogics, Inc.

Radiology

LLZ

FDA Database of AI/ML

Riverain Medical
Group,Llc

Radiology

LLZ

FDA Database of AI/MLJOY

FDA Database of AI/ML

2012/12/27

K123526

ClearRead +Confirm

2012/8/1

K121197

BodyGuardian Remote
Monitoring System

2012/5/17

K120489

2012/4/13

K120161

AlphaPoint Imaging
Software2011/12/28

K111776

DeltaView Model 2.1

2011/9/16

K102778

CellaVision® DM1200 withthe body fluid application

CellaVision AB

Hematology

2010/6/1

K092967

Pathwork
Diagnostics, Inc.

Pathology

MedicaCorporation

Hematology

Tissue of Origin Test Kit
FFPE

Pathwork Tissue of Origin
Test Kit-FFPE

2010/5/12

K092116

EasyCell

2008/12/5

K080595

2008/9/12

K082483

CellaVision DM96 with the
body fluid application

The Medical Futurist

The Medical FuturistJOY

FDA Database of AI/ML

Cella Vision AB

Hematology

JOY

FDA Database of AI/ML

Quantra

Hologic, Inc.

Radiology

LLZ

FDA Database of AI/ML

2008/7/17

K081140

Visensia

OBS Medical

Cardiovascular

MHX

FDA Database of AI/ML

2008/5/15

K080762

IB Neuro, Version 1.0

Radiology

LNH

FDA Database of AI/ML

2004/2/10

K033840

CellaVision DM96
Automatic Hematology
Analyzer

Imaging
Biometrics, LLC
Cella Vision AB

Hematology

JOY

FDA Database of AI/ML

2001/3/15

K003301

DiffMaster Octavia
Automatic Hematology
Analyzer

CellaVision AB

Hematology

JOY

FDA Database of AI/ML

1997/3/11

K955841

Compumedics Sleep
Monitoring System

Computmedics
Sleep Pty. Ltd.

Anesthesiology

MNR

FDA Database of AI/ML

1995/8/1

P940029

PAPNET Testing System

Neuromedical
Systems Inc.

Pathology

The Medical Futurist

Information contained on this list was obtained from the following databases, supported by FDA, and was last updated 2022-08-18:
1. FDA Database of Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices. (https://www.fda.gov/medical-devices/software-medicaldevice-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices)
2. Medical AI Evaluation (https://ericwu09.github.io/medical-ai-evaluation/).
3. The Medical Futurist (https://medicalfuturist.com/fda-approved-ai-based-algorithms/)－ 57 －

RegionUSA

Device Name
Ablamap

Manufacturer
Ablacon
Web Site

Address
Wheatridge, CO USA

www.ablacon.com







Class Disease / Location

Modality

CE Marked
Yes
Yes

1

Atrial Fibrillation

Electrographic flow
mapping
Triage based onchat bot

CE DateEU

Ada

Ada Health GmbHwww.ada.com/

Berlin, Germany

1

Diagnostic
Assessment

EU

Brainance MD

Advantisadvantis.io/md

Greece / NL

2s

Brain

MRI

Yes

2018/3/20

EU

Veye Chest

aidencewww.aidence.com

Amsterdam
The Netherlands

2aLungs / Chest

CT

Yes

2020/11/5

EU

Aignostics

Aignostics

www.aignostics.com

Berlin, Germany

Pathology

Image

No

EU

AiServe

AiServewww.aiserve.co

Leipzig, Germany

AI Assist Device for
Blind

Camera, machine
visionNo?

In development

MRI

In development

UK

NA

Arete

www.aretemedtech.com

Cambridge, England

TBD

Chronic Disease Respiratory

UK

NA

Avalon AI

www.avalonai.mystrikingly.com

Cambridge, England

2aAlzheimer's / Brain

EU

Rayvolve

AZMed

https://www.azmed.co/

Paris, France

1

Musculoskelatal

X-Ray

Yes

UK

Healthcheck,
Symptom checker

Babylon health services

www.babylonhealth.com

60 Sloane Avenue,
London SW3 3DD

1Multiple

Triage based onchat bot

Self
DeclaredUK

NA

BenevolentAI

www.benevolent.ai

London, England

NA

EU

BoneXpert

VisianaUK

DiademBrainminer LTD

UK

e-ASPECTS

Brainomix®

EU

CaraCare

CaraCareDrug discovery
tools

Horsholm, Denmark

1

MSK

X-ray

Yes

London, England

1

Brain

MRI

Yes

www.brainomix.com

Oxford, England

2a

Stroke / Brain

non-contrast CT

Yes

www.cara.care

Berlin, Germany

1

Irritable Bowel
Syndrome

Smartphone App

Yes
Yes

http://www.bonexpert.com/
brainminer.co.uk

2018/5/11

EU

DentaliQ ortho

CellmatiQ

www.cellmatiq.com/

Hamburg, Germany

1dentalX-ray

EU

OptaliQ glauco

CellmatiQ

www.cellmatiq.com

Hamburg, Germany

2aglaucoma

Fundus Camera

EU

Cercare Perfusion for
CT and MRI

Cercare Medical

www.cercare-medical.com

Denmark1

Brain

CT / MR

Yes, MDD

EU

Cercare Stroke

Cercare Medical

www.cercare-medical.com

Denmark1

Brain

CT / MR

Yes, MDD

EU

Medical Monitoring
Solution

Chronolife

www.chronolife.net

Paris, France

2aPatient Monitoring

Multi-input:
Respiration, ECG,
Temp, activity

UK

Integrated Cognitive
Assessment (ICA)

Cognetivity Neuroscienceswww.cognetivity.com

Cambridge, England

2a

Dementia Diagnosis

Testing Software

Yes

2019/12/19

EU

INIFY

ContextVisioncontextvision.com

Stockholm, Sweden

2a

Prostate Screening

Pathology - Biospy

Yes

2020/6/29

EU

Deepc.ai

Deepc.ai

www.deepc.ai

Munich, Germany

TBD

Radiology

No

EU

TIRESYA

Digitec

https://www.digitecinnovation.com/en/Lecco, Italy

2b

MSK, Chest

X-ray

Yes

UK

Symptom Assessment
Health Risk
Assessment

Doctorlink

www.doctorlink.com

London, England

1

Diagnostic
Assessment

Triage based onchat botYes

EU

aBSI Automated Bone
Scan Index

Exini Diagnostics AB

www.exini.com

Sweden2aBone Cancer

X-Ray

Yes

Prostate Cancer

Nuclear Medicine
Camera ImageEU

PSMA-AI

Exini Diagnostics AB

www.exini.com

SwedenUK

NA

Exscientia

www.exscientia.ai

Oxford, England

USA

Autoderm

First Derm

www.firstderm.com

Berkeley, CA, USA

USA

Freenome

Freenomewww.freenome.com

South San Francisco,
CA, USA

2a

In development

In development

2017
In development

Drug discovery
tools

NA
Dermatology

Image analysis

2aCancer Detection

blood biomarkers

Skin Cancer
Prostate cancer

Image analysis
MRI

No

Sold as API Builder
in development

EU

Sherlog

Fuse-AIwww.sherlog.ai

Hamburg, Germany

2aEU

Sens.AI

Future Processing

sensai.eu/en

Poland

2s

Brain

MRI

Yes

USA

Triton System™

Gauss Surgicalwww.gausssurgical.com

Menlo Park, CA USA

2aBlood Loss /Obstetrics

Image Analysis

Yes

EU

BoneView

Gleamer.ai

Paris, France

2a

MSK

X-ray

Yes

Other

BioMind®

Hanalytics Pte Ltd

http://www.gleamer.ai/
www.biomind.ai

Singapore

2aBrain diagnosis

CT, MR

Yes

2015/11/4

Drug discovery
tools

UK

NA

Healx

www.healx.io

Cambridge, England

NA

EU

Breast-SlimView

Hera-Mi

Nantes, France

2aBreast

Mammography

Yes

EU

icolung

Icometrix

http://www.hera-mi.com
icometrix.com

Leuven, Belgium

1

lung

CT

Yes

EU

BrainMagix

Imagilys

imagilys.com

Brussels, Belgium

1

Brain

MRI

Yes

EU

IB Lab KOALA™

Image Biopsy Lab

www.imagebiopsylab.com

Vienna, Austria

1

Osteoarthritis / Knee

x-ray

Yes

2018
2019

EU

IB Lab PANDA™

Image Biopsy Lab

www.imagebiopsylab.com

Vienna, Austria

1

Pediatric Bone
Development

X-Ray

Yes

EU

IB Lab HIPPO™

Image Biopsy Lab

www.imagebiopsylab.com

Vienna, Austria

1

Dysplasia / Hip

X-ray

Yes

EU

IB Lab LAMA™

Image Biopsy Lab

www.imagebiopsylab.com

Vienna, Austria1

Leg geometry

X-ray

Yes

Asia

InferRead CT
Pneumonia

InferVision

http://www.infervision.com/

Beijing, China

2a

Chest

CT

Yes
Yes

Asia

JBA-01KJLK Inc.

www.jlkgroup.com

Seoul, Korea

1

Cerebral Aneurysm

MRI

Asia

JBS-04KJLK Inc.

www.jlkgroup.com

Seoul, Korea

1

Brain ICH

CT

Yes

Asia

JBD-01KJLK Inc.

www.jlkgroup.com

Seoul, Korea

1

Breast

Mammography

Yes

1

Brain Segmentation

MRI

Yes

Brain Stroke

MRI

Yes

Asia

JAD-02KJLK Inc.

www.jlkgroup.com

Seoul, Korea

Asia

JBS-01KJLK Inc.

Seoul, Korea

EU

Kaia

Kaia Health Software GmbHwww.jlkgroup.com
www.kaiahealth.com/

UK

Mia™

Kheiron Medical

UK

EVA™

LabGenius

Munich, Germany

1

Back Pain

Support SoftwareYes

www.kheironmed.com

116 Old St, London,
EC1V 9BG

2a

Mammography independent 2nd
readerDeep Learning
Image Analysis

Yes

2018/10/2

www.labgeni.us

London, EnglandNA

Protein therapeutics

Drug discovery
tools

Asia

Lunit Insight CXR

Lunit

Lunit.io/en

Seoul South Korea

2a

Chest

X-Ray

Yes

2019

Asia

Lunit Insight MMG

Lunit

Lunit.io/en

Seoul South Korea

2aBreast

Mammography

Yes

2020

EU

mdbrainMediare GmbHwww.mediare.de/en/

Berlin, Germany

?

Head

MRI

Yes

Other

Smart Reports

Medicus.ai

medicus.ai

Dubai

1

Wellness App

Smartphone

Yes

UK

NA

Medopadwww.medopad.com

London, EnglandMultiple applications

AI Tools－ 58 －EU

Vara

Merantix Healthcare

https://www.varahealthcare.com/Berlin, Germany

2aBreast

Mammography

Yes
Yes

Oct-19EU

Veolity

MeVis Medical Solutions AG

https://www.veolity.com/

Bremen, Germany

2a

Chest

CT

USA

RevealAI Lung

Mindshare Medical

https://mindsharemed.com/

Seatle, WA, USA

TBD

Chest

CT

EU

PatchAi®

Mosaic Software Srl

www.patchai.io

Padova, Italy

NA

EU

Breastscape v1.0

Olea Medical

https://www.olea-medical.com/

La Ciotat, France

2aBreast

MR

Yes

EU

ChestEyeOxipitwww.oxipit.ai

Vilnius, Lithuania

2a

CAD

X-ray

Yes

2018/4/14

USA

Paige Insight

Paige AI, Inc.

paige.ai

New York, NY

2aGeneralPathology

Yes

2019/11/12

USA

Paige Prostate

Paige AI, Inc.

paige.ai

New York, NY

2a

Prostate

Pathology

Yes

2019/11/12

USA

Paige Prostate Grading
and Quantification

Paige AI, Inc.

paige.ai

New York, NY

2a

Prostate

Pathology

Yes

2020/12/8

USA

Paige Breast

Paige AI, Inc.

paige.ai

New York, NY

2aBreastPathology

Yes

2020/12/8

Asia

DISCOVERY

Pentax Medical

pentaxmedical.com

Japan

2a

GI

Colonoscopy

Yes

2019/12/1

EU

Promaton® Apox

Promatonwww.promaton.com

Amsterdam
The Netherlands

2a

DentalX-Ray

EU

QMENTA CareQMENTAwww.qmenta.com

Barcelona, Spain

2a

Neuro

AI Tools for image
analyisEUQUIBIM Care

Quibimhttps://quibim.com/

Valencia, Spain

2a

Biomarkers in Boneor brain

MR CT XR

Clinical Trial Data
Collection

In development

Yes

2019/5/29
2018/5/31

Other

qXR

Qure.ai

www.qure.ai

Mumbai, India

2a

Tuberculosis / Chest

X-ray

Yes

EU

RbkneeRadiobotics

https://radiobotics.com/

Copenhagen, Denmark

1

MSK

X-ray

Yes

UK

KidneyIntelX™

Renalytix AI plc

www.renalytixAI.com

Cardiff, UK

2a

Kidney disease

blood biomarkers
and electronic healthrecordAsia

Auto Lung Nodule
Detection

Samsung

https://www.samsunghealthcar
e.com/

Seoul, Korea

2a

Chest

X-ray

Yes

2a

Lung Cancer orPneumonia

CT

Yes

Asia
EU
EU
EU
EU

EU

SenseCare-Lung Pro

SenseTimeChina

www.sensetime.com

IDE Study in US

2020/11/4

www.mediktor.com

Barcelona, Spain

1

General Health

Triage based on
Chat Bot

www.thirona.eu

Nijmegan
The Netherlands

2aTuberculosis risk
score

X-ray

Yes

www.thirona.eu

Nijmegan
The Netherlands

2a

Chest

CT

Yes

2020

Thirona

www.thirona.eu

Nijmegan
The Netherlands

2a

Chest

X-Ray

Yes

2020

Tieto Intelligent
Wellbeing

Tieto

www.tieto.com/en/what-wedo/data-and-ai/tieto-intelligentwellbeing/

Norway2a?

AI Tools andSolutions

Yes

Mediktor
CAD4TBCAD4COVID-CT
CAD4COVID-Xray

Teckel Medical
ThironaThironaUK#BeInControl

Vine Healthwww.vinehealth.ai

London, England

1

Cancer Treatment

Support Software

Asia

VUNO Med - BoneAge

Vuno

www.vuno.com

Korea

2a

Hand

X-Ray

Yes

2020/7/30

Asia

VUNO Med DeepBrain

Vuno

www.vuno.com

Korea

2a

Brain

MRI

Yes

2020/7/30

Asia

VUNO Med - Chest XRay

Vuno

www.vuno.com

Korea

2a

Chest

X-Ray

Yes

2020/7/30

Asia VUNO Med - Fundus AI

Vuno

www.vuno.com

Korea

2a

Retinal disease

Fundus Camera

Yes

2020/7/30

Asia

VUNO Med - LungCT
AI

Vuno

www.vuno.com

Korea

2a

Chest

CT

Yes

2020/7/30

UK

Symptom Checker
Health A-Z, etc.

1

Diagnostic
Assessment

Triage based onchat botYes

2018/2/4

Health Monitoring

SW pairs with
Smartwatch

Yes

EU

Tidda AIYour.MD
Zana

www.your.md
www.zana.com

London, England
Germany－ 59 －1
Device NameDEEPVESSELFFRManufacturer

Beijing Keya Medical

Neo ECG T180 Lepu

Application

Modality

Certificate No

Coronary Artery diseaseCleared Date

2020-01-15

Heart rhythms

Class

ExplanationIII

DeepVessel FFR is a software medical
device that uses deep learning technology toperform a non-invasive physiological
functional assessment of the coronary
arteries using coronary computed
tomography angiography (CTA) scans. The
software processes coronary CTA images
semi-automatically, generates a threedimensional model of the coronary artery
tree and computes non-invasive DVFFR
values. A PDF report of the derived
information is sent electronically tophysicians

III

Software for ECG analysis
Diagnostic software for MRI images of
intracranial tumors

IntracranialtumourDiagnostic
Support

BioMind

MRI images

III

AI-aided diagnosis of 16 types of intracranialtumours has been achieved by machinelearning from vast volume of tumour images
confirmed by pathological ground truth
Predict details such as location, size,
characteristic, contour, signal andenhancement features
Precise segmentation and qualitative
analysis of cerebral small vessel diseases(CSVD) using MR image sequences

Cerebral Small
Vessel Disease
BioMind
Diagnostic
Support

Qualitative and quantitative volumetricassessment of CSVD lesions with in 15
seconds

Intracerebral
Haematoma
Expansion Risk BioMind
Assessment
SupportCT scans to accurately predict and segment
IPH (Intracranial Parenchymal
Haemorrhage) lesion
Automated calculation of blood clot andevaluation of hematoma expansion risk

CerebralDoc

Shukun Technology

this product relies on the original medical
image processing technology and AI image
algorithm of Shukun Technology, which candisplay, process and analyze head andcarotid CT angiography images, and can beused to detect whether there is 50% or more
stenosis in head and carotid arteries.
Assisted in triage evaluation and intelligently
output structured reports, greatly improving
the efficiency and accuracy of doctors’
diagnosis.

FFRDocShukun Technology

CT

RT-Viewercontour

Linking Med

Head and neck2022-04-14

III

2019-0320193210606

III

Automatic segmentation and image analysis
technology based on CT and MR
Fully automatic transmission of image data

Sunkun AI

Yukun Network TechiQMR-SW-P

Medic Vision Imaging Solution

Harmony

myPKFit for
ADVATE

coronary artery

Topcon Healthcare Solutions opathalmic

Baxalta US

2021-02-23

II

For processing coronary artery CT images
and displaying coronary artery calcificationscore2021-01-18

II

For processing MRI images and improving
signal-to-noise ration of MRI images. Onlyfor clinical referenceII

For reception, transmission, display,storage, measurement,
and output of ophthalmic medical images andvideos; andmanagement of patient and diagnostic data,clinical information,and ophthalmic diagnostic instrument reports
for clinicaldiagnosis and treatment.

III

For hemophilia patients (>16 years; >45 kg).
Individual
coagulation factor FVIII PK parameter isestimated, based oncoagulation factor VIII laboratory data andpersonal information,and preventive treatment (regular alternative
treatment) dose
calculated based on that parameter. Used by
HCPs familiar withhemophilia treatment.b

2020-12-31

hemophilia

2020-11-17－ 60 －

InferRead CT
Lung

Beijing Juixian Tech orInfervision

CoronaryView

Shanghai Xingmai Information coronary CT image
Tech
processing

chest CT images

2020-11-09

III

For display, processing, measurement, andanalysis of chest
CT images. Cannot be used as basis forclinical diagnosis andtreatment decision making alone.

2020-09-25

II

For importing, processing,c displaying, andbasic edititing operations, excluding auxillary
diagnostic functions.

Beijing Bailingyun Biomedical
MyoFlowQ-Lite
Technuclear medicine heart
image processing

2020-09-07

II

Used by nuclear medicine and submission
doctors to display,process, archive, report, and transmit
nuclear medicine heart
images.

OsteoGram
2000

Bone mineral density

2020-09-07

II

For estimating bone mineral density andhelping assess
fracture risk and monitor bone masschanges.

CompuMed, Inc.

AIDRscreening Shenzhen Siji Intelligent Tech.

diabetic retinal lesions eye
image diagnostic

2020-08-07

III

For analysis of the colored eye image ofadult diabetic
patients, and to provide medical practitioners
with supporting
diagnostic recommendations for the visible
retinal lesions ofdiabetes.

Mimics Medical Materialise NV

Medical image processing

2020-01-15

II

Suitable for browsing, storage, transmission,
display, and processing of medical images,
not suitable for breast X-ray images

HABMCMCN00
03 (Brain
Hanalytics Pte Ltd
Tumour
Application)

diagnostic support

2020-06-09

III

For displaying and processing MRI images.
Based on analysis
of T1WI, T2WI, and ce-t1wi MRI images,
assists imaging doctors
in classifying tumorsd in children andpatients >10 years.e

VSTP

medical and CT image
processing

2020-04-15

II

For displaying, processing, and measuring
CT, MR, and XA
images.

Canon Medical Systems

syngo.CT
Clinical
Extensions

Siemens Healthcare GmbHCT images analysis andprocessing

2020-03-30

III

For displaying, processing, measuring, andanalysing CT
images; vascular expansion function is used
for display andmeasurement of vascular structure andlesions.

syngo.via
View&Go

Siemens Healthcare

CT images analysis andprocessing

2020-03-12

II

Clinical function modules include patient
information
browsing; image viewing and tools.

Xiaoyi robot

iFLYtek

Note: This is being used widely but not sure
if it was approved through NMPA

Pulmonary
nodule CT
image assisted Deepwise
detection
softwareLung

2020-12uAI
United Imaging
EasyTriage-Rib

musculoskeletal

2020-11

DR-Sight

Lung-Sight

Imsight Technology

Imsight Technology

BoneAge-Sight Imsight Technology

Rib-Sight

Imsight Technology

Chest X-ray A.I assisted
diagnosis system

DR-Sight can identify up to 18 pulmonary
lesions, such as tuberculosis, pneumothorx,
pleural effusion, etc. It can help doctors toquickly screen for signs, identify location oflesions, and automatically generate
structured reports. DR-Sight is widely usedin medical institutions and hospitals.

CT Pulmonary nodule A.I.
diagnosis system

Lung-Sight enables patient data
management, automatically detects lesions,generates structured report with clinicalmanagement guidelines, provides informaiton
on nodule-s nature and features with follow
up function. This greatly improves the speed
and quality of doctor's analysis.

Bone Age X-Ray AI-Aided
Diagnosis System

BoneAge-Sight can perform diagnosis on the
X-ray film using A.I. The bone age can bedetected in milliseconds and the result isaccurate up to 1 month. The report is
automatically generated with fast speed andhigh accuracy. It can be widely used.

Rib Fracture AI
Identification System

Rib-Sight can rapidly and reliably identify rib
fractures on cest X-rays and CT. The rib
fracture identification on X-ray and CT
images can be combined with DR-Sight andLung-Sight respectively to maximize theanalytic value of X-ray and CT images.

－ 61 －

Liver-Sight

Cervical-Sight

Breast-Sight

Imsight Technology

Imsight Technology

Imsight Technology

Liver Cancer AI Screening
SystemScreening for liver cancer enables early
diagnosis and possible in-time treatment
decision. CT and MRI are commonly used toscreen for liver cancer. Liver-Sight can
detect liver lesions from medical images andlocate the lesion areas. Each lesion isquantitatively and qualitatively analyzed, andreport is generated according to LI-RADS
guideline.

Cervical Liquid-Based Cell
AI Screening System

Cervical-Sight uses a deep learningtechnique based on convolutional neuralnetworks to enable automated analysis of
cervical fluid-based cytopathic images. It
allows rapid screening, able to locate andclassify diseased cells according to TBS
guidelines, and detection of microbial
infections. Diagnosis is made throughintelligence analysis and ultimately generate
test reports.

AI detection of lymph nodemetastasis in breast
cancer

Detection of lymphatic metastasis based on
pathological images is a key indicator ofbreast cancer staging diagnosis. BreastSight can automatically and accurately
delineate the metastasis area on pathologicalsection, measure the size of the metastatic
lesion and therefore faciliatate in locating
metastasis area and determining the staging
to prevent any misdiagnosis.

Cervix-Pilor

Imsight Technology

Contouring System for
Target Area of Cervical
Cancer

The AI can quickly and accurately delineate
the target area and the organs at risk.
Through DVJ-I automatic calculation andorgan recognition, the radiotherapy process
can be simplifeied and shortened fromseveral hours to several minutes. A.I. acts
as an auxiliary tool and assists doctors incompleting tumor radiotherapy moreaccurately and efficiently.

Landing Med
AI+CloudLanding Med

Cancer detection

Automatically detects suspicious cells forpre-cancer detection

DR AI-assisted
HY Medical
Bone Fracture

Bone fracture in x-ray
imgaesCT AI-assisted
HY Medical
Rib Fracture

Rib fracture in CT images

Auto-detection of fracture in CT images

QCT BoneHY Medical
Mineral Density

Bone denisty
measurement

Auto spiral segmentation and bone density
measurement. Auto detection of vertebral
height, CT mean value, BMD parameters.

CT AI-assisted
HY Medical
Pneumonia

Lesion detection in CT
imagesBatch screening and output result inseconds, provides volume and occuptaion oflesions, auto-calibration and comparison for
disease trend track

CT AI-assisted
HY Medical
Lung Nodule

Lung nodule detection in
CT images

Lung nodule detection; risk prediction andprobability; 3D volume reconstruction

DR AI-assisted
HY Medical
Pulmonary TB

TB diagnosis

Auto batch operation of DR images; accurate
and fast diagnosis

Mammography
HY Medical
AI Diagnosis

Breast cancer diagnosis

AI-assisted image interpretation in early
screening of breast cancer' identify lesions,highlight and auto localization of lesions

Type B Aortic
Dissection

Cardiography

Auto-segmentation of aorta and branchvessels, auto-calculatesurgery parameters

HY Medical

III

Locate fracture in x-ray

FeianhaoDianeiExpert online consultation
platfor

The platform provides dozens of expert
doctors including radiologists, thoracic
surgeons, and respiratory experts for users
to conduct consultation for lung disease
cases. The user can upload lung CT image
file to get AI and expert doctor's
advertisement in a short time. This platform
is aimed at solving the problem of uneven
distribution of high-quality medical resourcesin China. Nodule segmentation, positioning,benign and malignant determination,
classification of invasiveness, and detection
are features of the AI.

Device namecould not be
identified.

JianPei Tech LTD

image-reading robot

Highly accurate image recognition to assist
in locating diseases, analyzing condiitons,
and guiding operations.

InferRead CT
Pneumonia

InferVision

pneumonia identification

Real-time identification and alert ofsuspected pneumonia cases

InferRead DR
Chest

InferVisiondisease identification from
X-ray images

InferRead DR Chest is desiged to be used
for the detection and notification of multiple
diseases by analyzing chest X-ray images,
including tuberculosis, fracture, pleural
effusion and pneumothorax

InferRead CT
StrokeInferVision

hemorrhage identification

Fast identification and alert of suspected
hemorrhage－ 62 －


DeviceCompanyItem

Masto Check Bertis, Inc.









Class Classification No.Manufacturing Approval No.Manufacturing Approval Date Intended Use

3

A24500

19-5

2019/1/3

This in vitro diagnosis device uses a mass
spectrometer (LC-MS/MS) to quanitfy the 3
proteins (APOC1, NCHL1, and CAH1) in humanblood plasma and applies the values to a breast
cancer diagnosis algorithm to assist with thediagnosis of stage 0, 1, and 2 breast cancer.
*Stage 0, 1, or 2 breast cancer diagnosis ortreatment methods cannot be determined based
solely on the test result obtained with thisproduct. Different clinical diagnosistic tests are
required for stage 3 or 4 breast cancer
diagnosis.

2018/5/16

A software designed to help healthcare
professionals determine the bone age of patientsby analyzing the X-ray image of the patient's left
hand based on the bone age model of theGreulich-Pyle (GP) method

VUNO MedBone AgeVuno, Inc

Analyser, Medical Image

JBS-01KJLK Inspection,
Inc

Computer Aided
Diagnosis Software3

18-573

2018/8/14

A software used to assist medical professional indiagnosing cerebral infarction (ischemic stroke)
by classifying its type automatically based onmagnetic resonance (MR) images and clinicaldata

Lunit Insight
CXR nodule

Lunit, Inc

Computer Aided
Detection Software2

18-5742018/8/14

A software that detects solitary pulmonary
nodules from chest X-ray images and calculates
the probability of lesions to help medical
professionals interpret the images

DeviceName cannot Clasrify, Incbe identified.

Computer Picture
Archiving andCommunication System,
Image Processing,
software2

16-4704

2018/7/17

A software that uses deep learning to separate
noise from low-dose (high-noise) CT images anddisplay/transmit noiseless images

EzOrthoEwoosoft, Inc

Telemetry System
Transmitter, Dental
Image

2

13-751

2013/4/26

A software used in devices that store, enlarge,
reduce, view, analyze, transmit, and display
dental images (uses the tracing with DAVIS Auto
Ceph Tracing) feature powered by AI learning toauto-generate landmarks and outlines)

Auto Lung
NoduleDetection

Samsung
Electronics, Inc

Computer Aided
Detection Software2

19-357

2019/6/7

A software that detects areas with suspected
single pulmonary nodules to help health-care
professionals in diagnosis

Computer Aided
Diagnosis Software

3

19-493

2019/7/29

A software that detects areas with suspected
breast cancer in mammographic images, marks
areas with suspected malginant lesions, anddisplays the probability of malignant lesions toassist the interpreting physicians in diagnosis

DeviceName cannot Lunit, Incbe identified.

2

18-360ATROSCANJLK Inspection,
Inc

Computer Medical
Software2

19-4654

2019/8/5

A software that uses medical images (brain MRI
images) to provide simulation treatments andprocedures as well as diganoses (uses CNN tolearn big data and analyze the volume of thecerebral substructure and the cerebral
substructure and the cerebral cortex atrophy.

Vuno Med
Chest X-ray

Vuno, Inc

Computer Aided
Detection Software2

19-551

2019/8/20

A software that detects abnormal areas in chest
X-ray images and highlight them with outlines
and colors to assist with Image interpretation

DS-CF-01

Deepnoid, Inc

Computer Aided
Detection Software2

19-5502019/8/20

A software that detects areas with suspectedcompression fractions in lumbar X-ray images tohelp health-care professoinals in making
diagnostic decisions

JDL-01KJLK Inspection,
Inc

Computer Medical
Software2

19-48222019/10/2

A software used in analysis devices to obtain
medical images and make them usable insimulation treatments, simulation procedures,and simulation diagnoses (lung image analysis)

DeviceJLK Inspection,
Name cannotInc
be identified.

Computer Medical
Software2019/10/4

A software used in analysis devices to obtain
medical images and make them usable insimulation treatments, simulation procedures,and simulation diagnoses (gastroscope image
analysis)

JFD-01AJLK Inspection,
Inc

Computer Medical
Software2

19-48292019/10/4

A software used in analysis devices to obtain
medical images and make them usable insimulation treatments, simulation procedures,and simulation diagnoses (colonoscopy image
analysis)

Lunit InsightCXR MCA

Lunit, Inc

Computer Aided
Detection Image
Processing, Software

2

19-6602019/10/21

A software that detects abnormal areas in chest
X-ray images to assist the interpreting physicanin making diagnostic decisions

2

19-4828－ 63 －MDAI-BA-01 Crescom, Inc

Analyser, Medical Image

2

A26430.11

20-1532020/3/3

A software designed to help healthcare
professionals determine the bone age of patientsby analyzing the X-ray image of the patient's left
hand using an AI technique that combines theTanner-Whitehouse3 (TW3) and Greulick-Pyle(GP) methods

Healthhub Co.,Ltd.

Analyser, Medical Image,
Software2

A26430.11

20-1662020/3/10

A software designed to help healthcare
professionals determine the bone age of patientsby automatically analyzing the bone age of thepatient's left hand in the X-ray image using theTW-3 method

Vuno, Inc

Opthalmic Image,
Computer Aided
Detection/ Diagnosis
Software2020/4/1

A software that assists healthcare professionals
in diagnoses by analyzing abnoraml findings infundus images, providing analysis results about
the normal and abnormal findings, commenting
about the abnormal findings, and highlighting theirlocations.

Vuno, Inc

Computer Aided
Detection and Diagnosis
Software2020/4/21

A software designed to detect nodules in CT
images of the lung and provide quantitative
information about the nodules to assist
healthcare professionals who interpret theimages in making diagnostic decisions

BoneAge.io

VN-M-03S

VN-M-04S

DN-CA-01

Deepnoid, Inc

AVIEW
Coreline Soft, Co,
LUNG
Ltd.
Nodule CAD

DeepDxProstate-v1

DL-LN-01

Deep Bio, Inc

Deepnoid, Inc

32

E08020.01

E11030.01

20-24420-298Computer Aided
Detection Software

2

A26430.16

20-4672020/6/10

A software which detects abnormal regions withsuspected cerebral aneurysm in humancerebrovascular MRA (Magnetic ResonanceAngiography) images using big data and artificial
intelligence (AI) technologies to assist healthcare
professionals in making diagnostic decisions

Computer Aided
Detection Software

2

A26430.16

20-4842020/6/10

A computer aided detection software used toautomatically detect lung nodules 4mm or larger
to 30mm or smaller in CT images of the chest
using AI technology

2020/5/19

An IVD medical device which assists physicianswith the diagnosis of prostate cancer by
analyzing the presence of cancer tissues indigital images of hematoxylin and eosin(H&E) stained prostate tissues from patients withsusepcted prostate diseases using a software

2020/7/16

A software which detects lung nodules, reigons
with suspected lung nodules, and the probability(%) of nodules in the relevant regions in lowdose CT images of the human chest using big
data and artificial intelligence (AI) technologies toassist healthcare professionals in making
diagnostic decisions

IVD Software for
Diagnosis

Computer Aided
Detection Software

3

2

P01000

A26430.16

20-37320-578

ML-02

MonitorCorporation, Inc

Computer Aided
Diagnosis Software

3

A26430.14

20-602

2020/7/27

A software used by the interpreting physician in
the interpretation of chest CT images; it provides
information about the probability of malignancy inlung nodules, location, and characteristics oflung nodules to assist in making decisions
regarding the final diagnosis and management ofpatients based on the informatoin extracted frommedical images

DrNoon for
FundusScreening

Medi-Whale, Inc

Computer Aided
Detection Software

2

A26430.16

20-6182020/8/3

A software that detects and highlights regionswith fundus abnormalities and suspecteddiseases (cataract, glaucoma, and retinal
diseases) to assist healthcare professionals inmaking diagnostic decisions

EyeView

AIMS, Inc

Computer Aided
Diagnosis Software

3

A26430.14

20-8472020/9/28

A software used to assist the physician in
making diagnostic decisions about glaucoma
based on retinographs of the patient taken withthe fundus camera

Vuno, Inc

Neural Image, Computer
Aided
Detection/Diagnosis
SoftwareA software that automatically analysis T1
weighted MR images of the brain and digitizes
the probability of Alzheimer's disease to assist
healthcare professionals in making diagnostic
decisions

VN-M-07

VeriSeq
Other Software, ClassNIPT Assay Illumina Korea, Ltd.
III, for IVD
Software V@

Transpara

EzOrtho

Siemens
Healthineers, Inc

Ewoosoft, Inc

Computer Aided
Diagnosis Software

Analyser, Medical Image,
Software3

E06090.01

20-1159

2020/12/29

3

P20010.02

20-1362020/6/17

3

2

A26430.14

20-18720-4020－ 64 －

2020/8/21

A software that detects areas with suspected
breast cancer in mammographic images, marks
the locations of malignant lesions, and displays
the probability of malignant lesions as a score toassist the interpreting physician in diagnosis

2020/1/9

A software used in analysis devices to obtain
medical images and make them usable insimulation treatments, simulation procedures,and simulation diagnoses (uses the tracing with
DAVIS (Auto Ceph Tracing) feature powered by
AI learning to auto-generate landmarks andoutlines)

JVIEWER-X

JLK Inspection,
Inc

Picture Archiving andCommunication System,
Image Processing,
Software2

20-40292020/1/13

A software used in devices which save, enlarge,
reduce, view, analyze, send, and print medical
images (lung image analysis)

JVIEWER-XJLK Inspection,
Inc

Analyser, Medical image,
Software2

20-4030

2020/1/13

A software used in analysis devices to obtain
medical images and make them usable insimulation treatments, simulation procedures,and simulation diagnoses (lung image analysis)

AVIEW

Coreline Soft, Co,
Ltd.

Picture Archiving andCommunication System,
Image Processing,
SoftwareDeviceINFINITT
Computer Aided
Name cannot
Healthcare C., Ltd Detection Software
be identified.

DeviceName cannot Rayence, Incbe identified.

DeviceName cannot Rayence, Incbe identified.

DEEP:CHES
Deepnoid, Inc
T-XR-01

Analyser, Medical Image,
Software

Computer Aided
Detection Software

Analyser, Medical Image,
Software2

16-46032020/2/17

A software used in devices which save medical
images, view, analyze them using the enlarging,
reducing, splitting, and adjusting functions, send,
and print the results of the analysis (AItechnology is used to auto-split lung regions)220-4154

2020/2/25

A software used to detect abnormal regions(raised or depressed patterns) in colonoscopy
images and highlight them with outines to assist
healthcare professionals in making diagnostic
decisions

2020/4/10

A software used in devices with save, enlarge,
reduce, view, analyze, and send medical
images: it includes the software designed to help
medical staff determine the bone age of patientsby analyzing the X-ray image of the patient's left
hand based on the bone age model of the GP(Greulich-Pyle) method

2020/4/10

A software used in devices with save, enlarge,
reduce, view, analyze, and send medical
images; it includes the function that detects
abnormal regions in chest X-ray images andhighlights them with outlines and colors to assist
wiht the interpretation of the images and thesoftware designed to help medical staff
determine the bone age of patients by analyzing
the X-ray image of the patient's left hand basedon the2020/5/15

A software used in analysis devices to obtain
medical images and make them usable insimulation treatments, simulation procedures,and simulation diagnoses (a function that finds
the form, size, and location of bright regions witha round shape in X-ray images)

2020/5/20

A software used in analysis devices to obtain
medical images and make them usable insimulation treatments, simulation procedures,and simulation diagnoses (analyzes optic cups,
optic discs, and bright regions in fundus images)

2020/5/20

A software used in analysis devices to obtain
medical images and make them usable insimulation treatments, simulation procedures,and simulation diagnoses (analyzes fatty andmuscular regions of abdominal CT images)

2

2

2

20-4273

20-4274

20-4378JLK Inspection,
Inc

Analyser, Medical Image,
SoftwareDeviceJLK Inspection,
Name cannotInc
be identified.

Analyser, Medical Image,
SoftwareDeviceJLK Inspection,
Name cannotInc
be identified.

Analyser, Medical Image,
Software2

20-4404

2020/5/21

A software used in analysis devices to obtain
medical images and make them usable insimulation treatments, simulation procedures,and simulation diagnoses (analyzes brightregions in brain CT images)

JLK Inspection,
Inc

Analyser, Medical Image,
Software2

20-4405

2020/5/21

A software used in analysis devices to obtain
medical images and make them usable insimulation treatments, simulation procedures,and simulation diagnoses (analyzes dark regionsin brain CT images)

DeviceJLK Inspection,
Name cannotInc
be identified.

Analyser, Medical Image,
Software2

20-4406

2020/5/21

A software used in analysis devices to obtain
medical images and make them usable insimulation treatments, simulation procedures,and simulation diagnoses (analyzes brightregions in breast CT images)

2020/5/28

A product which records, saves, and transmits
single channel electrocardiogram signals: themeasured signals are used in analyzing thenormal state, atrial fibrillation, bradycardia,
tachycardia, etc, through an algorithm to assist
healthcare professionals in diagnosis (assists inthe diagnosis of arrhythmia using the information
about atrial fibrillation, tachycardia, etc, analyzed
through an algorithm)

2020/6/1

A device or software which saves, enlarges,
reduces, views, analyzes, sends, and prints
medical images (a function that analyzes boneages and detects abnormal chest regions has
been added by adding a previously approved
software)

JOD-01A

JBS-04A

DeviceSynex Consulting
Name cannot
Ltd.
be identified.

Electrocardiographic
Holter Analyser

DeviceName cannot Listem
be identified.

Medical Image, Analog to
Digital Transform, DR,
CR

2

2

2

2

20-4398

20-4399

20-11508-226－ 65 －

Device
Samsung Medison Analyser, Medical Image,
Name cannot
Co., Ltd.
Softwarebe identified.

2

20-4468

2020/6/2

A software used in analysis devices to obtain
medical images and make them usable insimulation treatments, simulation procedures,and simulation diagnoses (provides information
about classification, splitting, and measurementof ultrasonographic images of the standard fetal
heart)

Laon People, Inc

Picture Archiving andCommunication System,
Image Processing,
Software2

19-4368

2020/6/11

A software used in analysis devices to obtain
dental images and make them usable insimulation treatments, simulation procedures,and simulation diagnoses (automatically extracts
54 landmarks learned using lateral X-ray images
based on AI technology)

DeviceCoreline Soft, Co,
Name cannot
Ltd.
be identified.

Analyser, Medical Image,
Software2

20-46312020/7/16

A software that splits organs according to theirclassifications based on a split model trained withCT (chest) images by AI

DeviceName cannot Rayence, Incbe identified.

Medical Image, Analog to
Digital Transform, DR,CR

2020/7/20

A device which digitizes medical images using
computer-aided radiographic imaging devices(CR) and digital radiographic images devices(DR), saves, and sends the images; it often
includes a software

2020/8/6

A software used in analysis devices to obtain
medical images and make them usable insimulation treatments, simulation procedures,and simulation diagnoses (automatically detects
regions in the spine that are darker than thesurroundings)

2020/8/12

A software used in analysis devices to obtain
medical images and make them usable insimulation treatments, simulation procedures,and simulation diagnoses (highlights brightregions with round shapes in breast CT images)

2020/8/12

A software used in analysis devices to obtain
medical images and make them usable insimulation treatments, simulation procedures,and simulation diagnoses (automatically detects
the spine at both ends of curvatures)

2020/8/13

A software used in analysis devices to obtain
medical images and make them usable insimulation treatments, simulation procedures,and simulation diagnoses (automatically detects
bright regions in the brain)

2020/8/13

A software used in analysis devices to obtain
medical images and make them usable insimulation treatments, simulatino procedures,and ismulation diagnoses (automatically detects
dark regions near dental roots)

LaonCeph220-4639

Deepnoid, Inc

Analyser, Medical Image,
SoftwareDeviceName cannot Deepnoid, Incbe identified.

Analyser, Medical Image,
Software

DS-SC-01

Deepnoid, Inc

Analyser, Medical Image,
SoftwareDeepnoid, Inc

Analyser, Medical Image,
SoftwareDeviceName cannot Deepnoid, Incbe identified.

Analyser, Medical Image,
SoftwareDeviceName cannot Deepnoid, Incbe identified.

Analyser, Medical Image,
Software2

20-47612020/8/18

A software used in analysis devices to obtain
medical images and make them usable insimulation treatments, simulation procedures,and simulatio ndiagnoses (highlights raised
regions in gastroscopy)

DeviceName cannot Deepnoid, Incbe identified.

Analyser, Medical Image,
Software2

20-47622020/8/18

A software used in analysis devices to obtain
medical images and make them usable insimulation treatments, simulation procedures,and simulation diagnoses (highlights raised
regions in colonoscopy)

DC-XR-03

Analyser, Medical Image,
Software2

20-4764

2020/8/19

A software used in analysis devices to obtain
medical images and make them usable insimulation treatments, simulation procedures,and simulation diagnoses (automatically detects
the lung regions in chest X-ray images)

2020/8/26

An online-based brainwave analysis softwarethat classifies mild cognitive impairments known
as the stage prior to Alzheimer's dementia inpatients with amnestic mild cognitive impairment(aMCI) through a quantitative brainwave
analysis; it presents the results of brainwave
analysis by displaying the probability of aMCI asa percentage based on a trained aMCI model toassist healthcare professionals in diagnosis

2020/9/2

A software used in analysis devices to obtain
medical images and make the usable insimulation treatments, simulation procedures,and simulation diagnoses (Automatically detects
and visualizes intervertebral discs in lateral MRI
images of the spine)

2020/9/2

A software used in analysis devices to obtain
medical images and make them usable insimulation treatments, simulation procedures,and simulation diagnoses (visualizes the lungregions in chest CT images)

DS-BM-01

DN-HE-01

iSyncBrain

Deepnoid, InciMediSync, Inc

Electroencephalograph,
Analysis Software

DeviceName cannot Deepnoid, Incbe identified.

Analyser, Medical
Images, Software

DC-XR-03

Analyser, Medical
Images, Software

Deepnoid, Inc

2

2

2

2

2

2

2

2

20-4709

20-4742

20-4743

20-4749

20-4751

20-75020-4804

20-4805－ 66 －

Device
Medical Supply,
Name cannotInc
be identified.

Bladder Volume
Measurement System,
Ultrasonic2

20-4609

2020/9/16

A device that measures the volume of bladders
using ultrasonic waves (highlights the bladderregions in ultrasonic images)

DeviceGE Healthcare
Name cannot
Korea Co., Ltd.
be identified.

Ultrasound Imaging
System, GeneralPurpose

216-4615

2016/9/29

A general-purpose ultrasound imaging systemthat transmits ultrasound energy to affectedareas (including cardiovascular areas), receives
reflected signals, and visualizes them (measuresthe distance of diastolic interventricular septum,
etc. in the heart area, labels different areas,
recognizes images, determines what types ofmeasurements are needed, and measures therelevant Auto Doppler)

ClariCT.AI

ClariPi, Inc

Picture Archiving andCommunication System,
Image Processing,
Software2

20-4233

2020/10/29

A software used in devices which save, enlarge,
reduce, view, analyze, send, and print medical
images (automatically splits the liver area anddisplays ROI; reduces noise in low-dose CT
images and increases the SNR of images)

Lunit Insight
CXR

Lunit, Inc

Computer Aided
Detection and Diagnosis
Software2

20-8962020/10/19

A software that detects abnormal areas in chest
X-ray images to help health-care professionals in
diagnosis

DeviceGE Healthcare
Name cannot
Korea Co., Ltd.
be identified.

Ultrasound Imaging
System, GeneralPurpose207-522

2020/11/2

A device that transmits ultrasound energy toaffected areas, receives reflected signals, andvisualizes the physiological or artificial structure(automatically senses and dispalys the central
nervous system (CNS) of the fetus)

DeviceName cannot Deepnoid, Incbe identified.

Analyser, Medical Image,
Software2

20-5104

2020/12/14

A software used in the analysis of medical
images (MRI images of the breast) (visualizes
the surface area of breast fibroadenoma tissues)
A software used in analysis devices to obtain
medical images and make them usable insimulation treatments, simulation procedures,and simulation diagnoses (automaticallyanalyzes MR images of the prostate andhighlights areas with low signal)

DeviceName cannot Vuno, Incbe identified.

Analyser, Medical Image,
Software2

20-5145

2020/12/23

DeviceSamsung
Name cannot
Electronics, Incbe identified.

Software for
Ophthalmology

221-4262021/5/27

DC-XR-03

Deepnoid, Inc

Computer Aided
Detection and Diagnosis
SoftwareDeep Bio, Inc

Computer Aided
Diagnosis Software for
Pathological Cell or
TissueDeepDxProstate-v1

Al-RadSiemens
Companion
Healthineers, Inc(Pulmonary)

Eclipse

Varian Medical
Systems Korea,
Inc

Computer Aided
Detection and Diagnosis
Software

Medical Image, Radiation
Treatment Planning
Software

Medipixel XA Medipixel, Inc

Cardiovascular Image,
Analysis Software

OPTINA

Alinsight Inc.

Ophthalmic Image,
Computer Aided
Detection/Diagnosis
Software

Alinsight Inc.

Ophthalmic Image,
Computer Aided
Detection/Diagnosis
Software

OPTINA

2

3

2

2

2

3

3

21-841

21-89821-27821-4020

21-4032

21-12221-123－ 67 －

2021/10/13

A software used in analysis devices to obtain
medical images and make them usable insimulation treatments, simulation procedures,and simulation diagnoses (automatically detects
the lung regions in chest X-ray images)

2021/11/11

A clinically validated and CR marked AI
diagnostic support software for prostate cancer.
The software analyzes digitized slide images of
Hematoxylin & Eosin stained prostate specimens
to detect and localize areas of interest. These
areas of interest are detected based on theirseverity in accordance with the Gleason Scoring
System.

2021/11/11

A software that provides post-processing ofimaging datasets through AI-powered algorithms.
The software includes the ability to provide lung
lobe segmentation, lung lesion detection andmeasurements, as well as vertebra bodysegmentation and measurement.

2021/1/14

A software utilized in simulation radiation therapy
and simulation procedures based on medical
images that have been obtained (AI technoloy isapplied to some structures to highlightinfluencers (structures around the treatment
target) in the Generate Contour process, where
anatomical structure are contoured, in the stage
where the treatment plan is established)

2021/1/15

A software used in the analysis of medical
images (cardiovascular images) (it shows thelevel of blood vessel blockage via simple
calculation into the pixel unit and information on
recommended stents, etc. in quantified values)

2021/2/18

A software which automatically indicates thepresence of glaucoma based on fundus imagesof the patient taken with the fundus camera tohealthcare professionals in making diagnostic
decisions

2021/2/18

A software which automatically indicates thepresence of age-related macular degradation
based on fundus images of the patient taken withthe fundus camera to healthcare professionals inmaking diagnostic decisions

3

21-1242021/2/18

A software which automatically indicates thepresence of diabetic retinopathy based on
fundus images of the patient taken with thefundus camera to assist heatlh-care
professionals in making diagnostic decisions

OPTINA

Alinsight Inc.

Ophthalmic Image,
Computer Aided
Detection/Diagnosis
SoftwareSwiftMRAirs Medical Co.,Ltd.

Class I Picture Archiving
and Communication
System, Image
Processing, Software

1

21-2402021/2/24

A software used in a device that saves,enlarges, reduced, views, and sends low-quality
MRI images taken faster than normal by applying
the AI deep learning technology and in a device
that prints the images

DeviceNeurophet Co.,
Name cannot
Ltd.
be identified.

Neural Image, Analysis
Software2

20-47712021/3/2

A software used in analysis devices to obtain
medical images and make them usable insimulation treatments, simulation procedures,and simulation diagnoses

HeuronParkinson

Heuron Co., Ltd.

Neural Image, Computer
Aided
Detection/Diagnosis
Software3

21-2572021/4/5

A software which automatically analyzes brain
MR images to assist medical staff in making
diagnostic decisions regarding Parkinson's
diseaseJKL, Inc.

Prostate Cancer Image,
Computer Aided
Detection/Diagnosis
Software2021/4/7

A software used to assist medical professionals
in making diagnostic decisions by automaticallyanalyzing the multi-sequential magnetic
resonance (MR) images of patients withsuspected prostate cancer and detecting thelocation of prostate cancer based on the images

JPC-01K

3

21-270PhenoCHES
PhenoMx, Inc.
T

Analyser, Medical Image,
Software2

21-4306

2021/4/14

A software used in analyzing medical images (asoftware which automatically detects lungregions in chest CT images using theConvolutional Neural Network (CNN), a depplearning model)

Assemblecircle
Co., Ltd

Dental Image, Treatment
Planning Software

2

21-44312021/5/20

A software which assists simulated treatment
and simulated procedures using dental images

DeviceName cannot Heuron Co., Ltd.
be identified.

Neural Image, Analysis
Software2

21-45202021/6/11

A software used in analyzing brain MR images

DeviceName cannot Vuno, Incbe identified.

Other Software, Class II,
for IVD

2

21-45432021/6/22

A software which detects, classifies, analyzes,
and saves specific cells in digitally scaned
images of tissue or cell specimen slides
according to specific colors, staining intensities,
cell sizes, patterns, and shapes

DeviceName cannot Clasrify, Incbe identified.

Class II Picture Archiving
and Communication
System, Image
Processing, Software

2

21-45492021/6/25

A software used in devices which save, enlarge,
reduce, view, analyze, send, and print medical
imagesAVIEW: CAC Coreline Soft, Inc

Cardiovascular Image,
Computer Aided
Detection/Diagnosis
Software

3

21-5542021/7/2

A software that detects the presence ofcoronary atherosclerosis accompanied bycalcified coronary lesions in CT images basedon AI to health0care professionals in diagnosis

JBA-01A

JLK, Inc

Neural Image, Analysis
Software2021/8/13

A software which automatically analyzes
cerebrovascular regions in the brain MRA
images of patients, calculates quantitative values
such as the location, length, volume, et. of thecerebrovascular regions, and provides them tohealth-care professionals

Alinsight Inc.

Opthalmic Image,
Computer Aided
Detection/Diagnosis
Software

3

21-7012021/8/19

A software which indicates the presence of adisease (glaucoma, age-related maculardegeneration, and diabetic retinopathy) based on
fundus images of the patient taken with thefundus camera to assist health-care
professionals in making diagnostic decisions

Neural Image, Analysis
Software2

21-46972021/8/12

A software which calculates quantitative values
such as the shape, size, location, etc. of brightregions in brain CT images and provides them tohealth-care professionals

2021/8/23

A software which analyzes a variety of vital
signs collected from the electronic medical
records, etc. of patients admitted in the generalward, shows the risk of heart failure as a scorewithin a range of 0 to 100, and sends it toelectronic medical records, monitoring devices
suhc as cetnral monitoring devices for patients,
etc., or user interface

WebCephOPTINA

DeviceName cannot Clasrify, Incbe identified.

DeviceName cannot Vuno, Incbe identified.

Vital Sign, Analysis
Software2

2

21-470221-709DeviceName cannot SK Inc
be identified.

Neural Image, Computer
Aided
Detection/Diagnosis
Software

3

21-7202021/8/26

A software which detects, highlights areas withsuspected cerebral hemorrhage in brain CT
images where contrast agents have not beenused and presents the likelihood of the areas
being diagnose as cerebral hemorrhage in apercentage to help health-care professionals
decide if brain hemorrhage has occurred andwhere it occurred.

iAID AID-U

Analyser, Medical Image,
Software2

21-47612021/9/1

A software which automatically analyzes
abdominal fat and muscle areas in abdominal CT
images, calculates their volume

iAID Co., Ltd.

－ 68 －

Device
Gwangrim
Name cannot
Meditechbe identified.

Endoscopic Image,
Computer Aided
Detection/Diagnosis
Software2

21-48392021/10/1

A software which assists in the detection ofabnormal areas such as dents and bumps inmedical endoscopic images by applying the deeplearning technology

iAID AID-UiAID Co., Ltd.

Analyser, Medical Image,
Software2

21-48552021/10/12

A software which automatically analyzes fat andmuscle areas in the thigh, claculates theirvolume, and provides them

DC-XR-03

Deepnoid, Inc

Computer Aided
Detection and Diagnosis
Software, Class II221-8412021/10/13

A software which detects abnormal areas(pneumothorax and pulmonary consolidations) in
X-ray images of the human chest using AI
technology to assist a physician in making
diagnostic decisions

2021/10/21

A software which detects abnormal areas
suspected of cardiovascular stenosis in
cardiovascular images to help health-care
professionals decide the diameter, length of thelesion, the degree of blockage of blood vessels,
and recommends the information of appropriate
stents, etc.

2021/11/11

A software which automatically analyzes
histological grades of prostate cancer in slide
images in the H&E staining WSI of the prostatebased on artificial intelligence which has learned
the Gleason grading system to assit thediagnosis of pathological cells or tissues

Medipixel XA Medipixel, Inc

Cardiovascular Image,
Analysis Software

DeepDxProstate

Computer Aided
Diagnosis Software for
Pathological Cell or
TissueDeep Bio, Inc2

3

21-4894

21-898DeviceName cannot Heuron Co., Ltd.
be identified.

Neural Image, Analysis
Software2

21-4995

2021/11/29

A software which segments brain regions inbrain MR images, calculates the volume and thethickness of the cerebral cortex, compares thecalculation result with that of a normal person,and provides the information (information on
volume and thickness) on brain atrophy tohealth-care professionals

Siemens
Healthineers, Inc

Computer Aided
Detection and Diagnosis
Software, Class II221-2782021/11/11

A software which processes lungs and lung
lobes in chest CT images using AI algorithms toassist clinicians in assessing pulmonary nodules

syngo.CT

DeviceName cannot Alinsight Inc.
be identified.

Ophthalmic Image,
Computer Aided
Detection/Diagnosis
Software3

21-9742021/12/2

A software which indicates the presence of adisease (glaucoma, age-related maculardegeneration, and diabetic retinopathy) based on
fundus images of the patient taken with thefundus camera to assist health-care
professionals in making diagnostic decisions

DevicePhantomics Co.,
Name cannot
Ltd.
be identified.

Cardiovascular Image,
Analysis Software

2

21-50172021/12/7

A software which segments and provides
myocardial regions after analyzing T2 map
images among MR images of the heart

DevicePhantomics Co.,
Name cannot
Ltd.
be identified.

Cardiovascular Image,
Analysis Software

2

21-5018

2021/12/7

A software which segments and provides
myocardial regions after analyzing native T1
map images among MR images of the heart

DeviceName cannot Deepnoid, Incbe identified.

Analyser, Medical Image,
Software2

21-5035

2021/12/14

A software which indicates the presence of darko rdiscontinuous regions in the wrist bone in Xray images of the wrist

AVIEW:
Neuro CAD

Neural Image, Computer
Aided
Detection/Diagnosis
Software2021/12/15

A software which detects brain hemorrhage (thepresence of brain hemorrhage and the amount ofhemorrhage) in brain CT image images ofpatients using AI technologies to assist
healthcare professionals in diagnosing brain
hemorrhage

2021/12/23

A softawre which detects abnormal regions(highlights them with outlines and colors) in chest
X-ray images to assist the physician in making
diagnostic decisions; it includes functions thatare used in devices that save, enlarge, reduce,view, analyze, and send medical images and in
devices that print them2021/12/28

A software which detects abnormal regions
which are different from normal regions incolonoscopy images, highlights them withoutlines, colors, reference lines, etc., andautomatically indicates the presence of adisease, the severity of a disease, or the
likelihood of a disease to assist health-care
professionals in making diagnostic decisions

Coreline Soft, Inc

DeviceJPI Healthcare
Name cannot
Co., Ltdbe identified.

Computer Aided
Detection and Diagnosis
Software, Class II3

2

21-101321-5065

DeviceName cannot Endo AI Co., Ltd.
be identified.

Endoscopic Image,
Computer Aided
Detection/Diagnosis
SoftwareDeviceMonitorName cannot
Corporation, Incbe identified.

Ultrasound Image,
Computer Aided
Detection/Diagnosis
Software, Class II221-50772021/12/29

A software used to detect abnormal regions
which are different from abnormal regions inmedical images and highlight them with colors orreference lines to assist healthcare
professionals in making diagnostic decisions

DeviceName cannot HDX C0., Ltd.
be identified.

Analyser, Medical Image,
Software2

21-45672021/12/6

A software which divides organs in CT images of
the chest, upper abdomen, head, and neck into
parts (it does not provide a user interface for thereview and editing of results)

221-5073－ 69 －

Device
Name cannot JKL, Inc.
be identified.

Neural Image, Computer
Aided
Detection/Diagnosis
SoftwareDeviceName cannot Medical AI
be identified.

Electrocardiograph,analysis software

2021/3/17

Software for the prediction of electrocardiogram
results and cardiac arrest within 24 h using AI
technology to analyze electrocardiograms

DeviceName cannot Heuron Co., Ltd.
be identified.

Neural image, computeraided detection /diagnosis software

2020/7/28

Software to aid in the diagnosis of Parkinson
disease using bran MRI images through theapplication of AI technology

DeviceName cannot Lunit Co., Ltdbe identified.

Medical image,computer-aided
detection/diagnosis
software2020/9/18

Software for the diagnosis of abnormal findings inchest X-ray images through the application of AI
technology. Nine abnormal findings such as
atelectasis, calcification, and fibrosis can be
identified.

DeviceName cannot Vuno Co., Ltdbe identified.

Vital Sign, Analysis
Software2020/9/22

Software for the prediction of cardiac arrest
through the analysis of vital signs using AI
technology

DeviceName cannot Laon People, Incbe identified.

Medical image,computer-aided
detection/diagnosis
softwareundergoing approval

Software for the diagnosis and assistance ofsleep apnea using AI technology to analyze
patient CT images and biometric information

DeviceName cannot Lunit Co., Ltdbe identified.

Breast cancer image,computer-aided
detection / diagnosis
software2021/9/2

Software for the diagnosis of breast cancer
based on mammography videos by applying AI
technology

DeviceName cannot Vuno Co., Ltdbe identified.

Electrocardiograph,analysis software

undergoing approval

Software for the detection of heart failure andmyocardial infarction, through the use of AI
technology to analyze electrocardiogram test
results

3

18-4254

2

2－ 70 －

2018/4/4









Entry

Registration #Date ofRegistration

45485

RZN 2020/12028

03.11.2020

Botkin.AI

LLC "Intellogik"

58.29.32.000

2b35318041787

RZN 2020/11137

11.12.2020

Neural network Care
Mentor AI system

LLC "CareMentorAi"

58.29.32.000

2a35318046522

RZN 2021/14449

27.05.2021

Celsus software

LLC "Medical Screening
Systems"

58.29.32.000

335318031.05.2022

The program of
automated analysis
of digital radiographsof the chest organs /fluorograms

LLC "FBM"

58.29.32.000

3353180

LLC "PTM"

58.29.32.000

335318049163

RZN 2022/17406

DeviceOrganization

BCR/JCC2Class

Type Code52350

RZN 2021/14651

24.09.2021

Software module forthe analysis ofhuman computed
tomography studies
according to TU
58.29.32-00221494354-2021

52540

RZN 2021/14627

22.06.2021

RADLogics Platform

LLC "RADLOGIX RUS"

58.29.32.000

335318027.07.2021

Neural network
system Save Mentor
AI for analysis of Xray projection
mammography

LLC "CareMentorAi"

58.29.32.000

335318012.10.2021

Neural network Care
Mentor AI system fordetermining
longitudinal flat feetaccording to the dataof lateral radiographyof the foot under load

LLC "CareMentorAi"

58.29.32.000

335318022.02.2022

Neural network Care
Mentor AI system fordiagnosing signs oflung cancer
according tocomputed
tomography

LLC "CareMentorAi"

58.29.32.000

3353180

JSC "YSAR+"

58.29.32.000

3353180

LLC "PTM"

58.29.32.000

3353180

54004

55337

58599

RZN 2021/14869

RZN 2021/15554

RZN 2022/16572

59007

RZN 2021/16120

23.12.2021

JEMYS:TELEMEDICINE witha decision support
system for the
analysis of X-ray
images of dicom
standard

59231

RZN 2022/16534

10.02.2022

Software module foranalysis of
mammograms－ 71 －

52488RZN 2021/14406

27.05.2021

Neural network Care
Mentor AI system fordiagnosing a newcoronavirus infection
COVID-19 according
to computed
tomography

41741

RZN 2020/9958

03.04.2020

System for supportof medical decisionmaking "WEBIOMED

LLC "K-LAB"

58.29.32.000

1178120o78311

FSZ 2009/03728

09.02.2009

LifeCycle Prenatal
Risk Assessment
Software

PerkinElmer Life & Analytical
Sciences, Vallac Oi, Finland,

94 4200

1

156770o80161

FSZ 2012/11938

18.04.2012

BoBsoft Molecular
Karyotyping Results
Analysis Software"Wallak Oi"

94 4200

1

15677003.12.2021

uPath HER2 Dual
ISH image analysis,
Breast Algorithm foranalysis of digital
images of breast
tissue on slides
LLC "Rosh Diagnostics Rus"stained by two-color
chromogenic
hybritization in situ todetermine the statusof the HER2 gene forin vitro diagnostics

58.29.32.000

2b32636003.12.2021

uPath PD-L1(SP263) image
analysis softwarealgorithm, NSCLC
Algorithm foranalyzing digital
images of non-small
cell lung cancer(NSCLC) tissue on LLC "Rosh Diagnostics Rus"
glasses stained withanimmunohistochemical
method to determine
the presence of PDL1 protein (SP263)
for in vitro
diagnostics

58.29.32.001

2b32636003.12.2021

uPath HER2 (4B5)
image analysis
software algorithm,
Breast Algorithm forthe analysis of digital
images of breast
tissue on slides
stained with an
LLC "Rosh Diagnostics Rus"
immunohistochemical
method for the semiquantitative
determination of the
HER2 protein (4B5)for in vitro
diagnostics

58.29.32.002

2b32636003.12.2022

uPath software forviewing andprocessing digital
images of object
glasses in in vitro
diagnostics

58.29.32.003

2b326360

57312

57316

57320

57324

RZN 2021/15856

RZN 2021/15850

RZN 2021/15852

RZN 2021/15855

LLC "CareMentorAi"

58.29.32.000

3353180

LLC "Rosh Diagnostics Rus"

－ 72 －

4608848227

o43272RZN 2019/8907

FSZ 2008/02607

FSZ 2010/08210

04.09.2020

Software for clinicalevaluation of theresults of molecularstudies of thebiomaterial ofpatients with
oncological diseases"Solo-report"
according to TU
58.29.32-00391709359-2018

LLC "Oncodiagnostics
ATLAS"

58.29.32.000

2a33316004.12.2020

Complex of hardware
and software for
automated
cytogenetic andmorphologicalstudies CytoLabView
with accessories

LLC "Intergen"26.60.12.119

2a33316018.11.2010

Automated systemfor documenting andanalyzinghybridization results
on GenoScan test
strips withaccessories

Hain Lifesteins GmbH,Germany

94 43702a333160－ 73 －









8>,




 2()  4:>,

－ 75 －Í~Phl¤±¼Åwh ®(Üv àl¤±¼Åwh(] e (r[Ç'1XÔ 6BF:JO(¿'"#ß

!

  !  CN7JH´¿qº$/k¦Ú¿Q%À$
CN7JH´¿qº$/k¦Ú¿Q%À0(!+ ¨°" À0/+%$ &¸vsovÌ1Ë( n¨°%ha ¡ak¦´¿É" À0/+%$ &ªz~Ì%Çn
$,.2@D9IO%À1T .0(!%iÈ1Ë( à%".Ú¿


áQ%À1¬m Ú¿áQ%1ejÇ$À1y*/""/U_S

 CN7JH´¿qº%¡v-´Å%Á]±%­x1Ë( ´Å%Ú¿18F>/"$,.¶',.¤#´¿ÄUV!ZÌ%®k!/XW$&w $Ñ/"1¯/ k¦©[1_" -ÕV%hÜ$,/+%$ &0(!%\¥%".CN
7JH´¿qº$ +ha¿× k¦uÏn¿×tf %¼)%n./+%"
\¥/
















Í~Phl¤±¼Åwh ®(Üv àl¤±¼Åwh(] e (r[Ç'1XÔ 6BF:JO(¿'"#ß

#*'$PW8S576Q%()*"WV!fX /.b&$LN_^GDK!H+

 % &
  #
" 
  
  
 $
  
 




 (









 ( 
 ! 
)
 
 
 #
 
 
 
 
 
 
 )

'

"





"





 !
! #
# 
 
 

¯¼f¶&ág4/'bÇdÕ· 8O>b9]eM=4
8OQ0A&$LN!,cC
E@S] 

(
!




)

µy uoyÇ4
Æ+ lÅ¾ T±'#¿






%


$








 ¥'k&1!
 ¬&oÍ[&ÚÜ!¾54/' Z'¬&p!¾54/' Z'¬&L^#!ÚÜ!¾54/'
 Zb¯¼É#!¾54/'
4

 S];Uj<?FPJ 3I7
ak7`62-T [ZB
i1:5
hª549:@;DÓ²xKÊ¢à²'k'4°7xK4
] 'nJ¯Ä'¬'Í!8aÅ½«¯&13¤ÐÁ½«¯&ß2%GBF'Ó²"41&%4



 




¯¼f¶&ág4/'

 !
! #
# 
 
 


 
 "



 hoÇj¹Í$"h¢Z'u"@?8
QË|/}s¬¹ 4¯¼f¶&ág%/'µy uoyÇ4
Æ+ lÅ¾ T±'#¿bÇdÕ·

'¹s.'d34¯¼f¶&ág%#v5z' d`[Ì"d4SQb×¼J'i(% ¬¾(»[«(¦r8Ã."¬¾(Ï¹8=DA5$'24°*24&¬¹½RS#YÄ(¨h#5VT')qÄ'È5$145 h¢Z8] $"3ÊS(dÑ'251('!")d^¹ÍhoÇj¹Í (´|/(j45

!0 %1863.:; -!) "257(4 
&#!¾

4

8'0,"!  :;  &/7+ @A7+54"&4'-/¬#Z'×¼N.&4/'"3¬#!¾4

G4hª549:@;Du¼'©'nJ



 


c

¯Ä'u¼ 7µu¼XÌ'\Z&Ã 4/'#!¯¼f¶&ág4

7µ4AH<EDfÞ
¬&14$)607

¯¼f¶&ág4/'










 !
! #
# 
 
 


 
 "



 hoÇj¹Í$"h¢Z'u"@?8
QË|/}s¬¹ 4 ¬¹m±×np(~ '5agÆØg(0'Àc_&R°'!"¸¶{( 'Ö\lb"5

µy uoyÇ4
Æ+ lÅ¾ T±'#¿bÇdÕ·

@?(wi8Q7&kh§¤(/8Q 1(
xjS,(y ¯8e_$CH<GEm(¼ÄWVT#1M(W­¿+·É'®³8£56-$9%&1( Ä Lf).#:F>#4©(¥(º8^51(#)& ¬¹m±(×np'!") CH<GE(¬¹m±×np'`5;:BG:I Ìt K UJ 8Ò6

 SyRbAUkr5*/#,+`[¯Ä&14u¼'

%




 ¥(p'2 " ¡ª'vÅ_'ÓÔ"º651(
 ^(¡ª'w"º651(
 ^(¡ª'Oc$"ÓÔ"º651(
 ^h¬¹Â$"º651(
5 P(hÁjÎ²Ä8Ã.Õµ¡ª241¬¹N(jpXVT)8w5&%"º?*%#*'$PW8S576Q Pz ¯Ð6239>4   623!) .#(1=%












 ¬¹m±×np(~ '5agÆØg(0'Àc_&R°'!"¸¶{( 'Ö\lb"5

qdP+'}r³7`[#AH<EDf'ÀÌTSQ"/I'T±Æ*»Ñ&²¸7 45,#8$%/' Ì

!(_Z¼ÔbjÎd¼Ô

9/*+ ,'#$&#!¾4?>'p~c7N6%eb§¡'.7N /'bW7Y#!2ÒP'_Ù&14/'&Ø×#Z'×¼N.&4/'"3¬#!¾4Ê¢à²R301&È'£®yÛ%$'à²7tÖ¨4 ¯Ä'¿Xw­'¦m7Ë-!¯Ä'×¼7=C@4#&13´)13%¯¼ÂOP"VÌ'©b"4SQ&(l{Ì&Ï4#/34a¯Ä'Ó²7µu¼XÌ'\Z&Ã4/'#!¯¼f¶&ág4Ø'Ó²7µ4AH<EDfÞ
Ê¢à²'k'4°7xK4¯¼f¶&ág%#v5z' d`[Ì"d4SQb×¼J'i(%






4

 |M'bÇdÕ·Ì7Ë-Ýº¬13/¯¼J'
dkUSQ(7p4%$!¾¯¼f¶&ág%/'

`[
¯Ä&14

%

 Lf).#:F>#4©(¥(º8^51(#)& ¬¹m±(×np'!") CH<GE(¬¹m±×np'`5;:BG:I Ìt K UJ 8Ò6 ibpkr5*/#,+

 Pz ¯Ð!=#)69;,'(2.

 1^\?WLR#(aMG`9$ W 1~X0W¯|fÒÍØÐ]/h&+7 5Hc\ :_|L5 }t^V Jw oyIu,9 Ð]#v(9Ð]<LO -µÂ#v(9 µÂ<LO0*"7°~%:9Ð]<LOARFRE; v&NYs  :_|L 
µÂ<LOÖÒÍ;àÞ&15Hy=>K5H  C@q;;\ÌY5ELµÂ<LO,0xl/¦')
e®

±Â5EL

"%  VlÌÚ§´/!+3a]F:_Qj<g}t^9$:1ÇÀ/¿»p#q%:)i4g¹/W vÙ/fÀÍ¸#c7:)

 ¥(p'2 " ¡ª'vÅ_'ÓÔ"º651(
 ^(¡ª'w"º651(
 ^(¡ª'Oc$"ÓÔ"º651(
 ^h¬¹Â$"º651(
5 P(hÁjÎ²Ä8Ã.Õµ¡ª241¬¹N(jpXVT)8w5&%"º¯¼f¶&ág%/'¯¼f¶&ág%#v5z' d`[Ì"d4SQb×¼J'i(%

@?(wi8Q7&kh§¤(/8Q 1(
xjS,(y ¯8e_$CH<GEm(¼ÄWVT#1M(W­¿+·É'®³8£56-$9%&1( Ä ¬¾(»[«(¦r8Ã."¬¾(Ï¹8=DA5$'24°*24&¬¹½RS#YÄ(¨h#5VT')qÄ'È5$145 h¢Z8] $"3ÊS(dÑ'251('!")d^¹ÍhoÇj¹Í (´|/(j45

T+87N5
J!&p7 d5'N2,%/h2,－ 76 －



?*%



"!

!=#)69;,'(2.

aMG`9




$

 W 1;B 7WMp mbv G .$-&+('0Xx
dE  =RKP?RB/¢×k.}c5Ø­;Y&=RKP?RB>=PC£ÑØ0dØª0j;($-/68!0)."0%fPl oyIu,9   !$)304'":#(<+.%981;

R) CMA7LO4n#ÃÛ¼4WA9>OÏ»ÕÌ
Y'_ ÁÃÛ¼EN8KG4k1'n1%$ÃÛ¼(©´4W:<?G$1
Qd$W32!pÉØ¡°'# ÁÃÛ¼'R4U« !Ö) ÁÃÛ¼(,(Ö'¦* ^Ë{ÃÛ¢4
!%4Æ+ g(%0¿2!

 




 /12&7-651
:*,+=.%981; R) ÓÒ¥ÈÇ/²2!Si(Ó49ODI=£m £ma(Ó4Ò¼(!
-'²1%4jc%#n1g(z'" R(yÀX4½!
#1.(%#¿2!

B,

&+XW
*'4H2H<A8)+6-'4

J+XW *'4KW *0"W(QL6-

>73UW
'4

NHQR
>73UW@T\^[W= Z5MP
UNTOYI

&?HJ

&14:(7²GBEK8) 9$7/
4<( 8#>4IFDMC;%>

 F:F &14&
3[% ;9#* "% 

E@FAM>30&?HJ7,

 Vl/!+ pÅ2=NI@QMHp-0¬Ü§´;s&)

?HJ<$B-*9?5

Ó|ZÎ¨ 
ß|ZÎ¨ wrZÎ¨ 



D75Z[CYBEUT

KNF3&)+UT











 







o0CN Gckpt[!3LD@|w($Gckpt[! 3LD@|w($ %iBN% iBN 8 dh*{ $ v'Gc^z" =J_?qV}E*UW(yj75 (  & ZHFs*u"qVaMf]`>Gckpt[qV)(kpIlv*:gf]e9;!qVA6 ZHFs*u"Gc^z<BbIY\6 KN XCqV*4 (oS#,-./+nmRO1CT> BP)xQ 1CT> :g]E r0*4 xQ 1CT> dh[2D~qV)(kpIlv

iBN 8 dh*{ $ v $,-./+nm :g(×Ù b×ÙÚ»§­ 0qÎ1\Z

J:@OV;3/2XU
!





nj0o



]=-0,J:@OV;.4Ð¸['"#ÄÞsÝ)





!










nj0o
qÎ&\ZqÎ1\Z

>HMO;·¶(}(ªÊ

¬¯³VY)x]4º*1
%$1mu©µ»ÈË¼²¾
nj0o

4oO
yMT?=
hn`9[

J:@OV;3/2XU#¿(]
Ñ`(¿
4gf1\ZoyhnzZ8~2

DeF



CN7JH´¿qº         ´¿qºCN7JH ´¿qº%CN7JH!/+%1 &01KgKg(/´¿qº1=%Z
 &~$/´¿? %:Q ´Å%Á]±1qy]%V# 1f*o $N ! +f#´¿1{/"1§"/# %Âx-(~
-D%4/%Âx-%iz&l* E1#bB!/)!&;Hf-J%)U1T .&^<`%$ %Q v
Q ^%q|Qo'x"Zhf=Q$#$y*-0/,%gY XA[%y1y*/*=%%|1/

78:+"$
4@& 45></-301#')$ hYgR\# 7:)i0CN

mu©µ»ÈË¼²¾

mu©µ»ÈË¼²¾

4oO

R0>HMO;·¶
¿(Ð¸mu©µ»ÈË¼²¾
nj`Äk.½0Ýy|«qÎ&\ZHICYBu©µ»ÈË¼²¾

 er e§­nj0o

@=(|á¨¹Ç'"#btc&

u©ÆvÔº0YÄk.½0Ôº

É0T¶t/68 s/Ï 3:)b^/GJ=C0Û·#ÃÊ(9$ GJ=C0Á/Õa³m#±(9$Ë;(/1[z0GD¡¤#¥{<>_A

R0Ýy|«CNÃÍpqÓ )¹¢¾E9O7AL;:4?M<$ K=3HßjG
O5O1n·Ò¹«³%Ê1âÙ/"!l¹Pµj$#!"(&' 
$ % )



{6X

k¦Ù(!%`$%ÎÞbnv%Ø²#¶dY


&)+UT" # !  $hn`9[ ]=-0,J:@OV;.4#Q ^%PniÈ$¥ v{8b$|Q §v/" %¡v1Ë(
k¦x<1$a^! +USV%Q2%x$/j )$Rar`c%ji$,.0k¦x<%OÀ1<!i/"1§"/]|!7T%=MO:
jitf$"/¡¶% wÌ1f*¯/#ji$\/pnÁC%[9&USV% C>%iZ$f!gy§"/]|!pnÁC$/31%(t¬V1f*¯/

%J2B826L%Ðrv1Ë(USVã»$k¦ÔÛ1{-0/"!
±db# 
%gY1§"/Âx- $ &%c1Ý"/d#k¦ÔÛ%¼)1w/]|!k¦Çn%£.]1¯/ }R½Æ%Ö^%¸vsov1Ë(m%k¦Çn0 /tq1
/^S"X ,0hf\&tq!d$tR1L4%R$¥R%1wa/ QK%wa&USV$ }R½Æ%Ö1{^´¿qº$/s b#[9r`,.,0hf]r$T ` ´¿qº%[9$/s b#U5Wmr$a&R dq !0'
R dqd¨° !0'=c"0 / ÎÞ7X!%Rar`%PniÈ1Ë( ÔÛ%#M1T %k¦\_r`-T^+{8b$ÕV0^S1@n/XW ¤Õ1\_"/^S!^³e>%Ö1¤<%¶!.I /^S1@n/XW# k¦uÏn¿×tf1n ÕV0^S1@n//
%* 1Pn/ÕV§#Y.%k/´¿q"$ k¦uÏn¿×tfÌ1#$@n!/ca1¬V/*7Ttf$ w(b#U¶+Ë(k(£.]1¯/
%GUSVu6b$k¦Ù1*FXW! +@n§#tf%£.]1¯/""+$USV%$¥ã»#\_d~§"#/Âx!¯1T(§#Y.ÕV{Ú/´¿q"!tf@n§"#/,gYUSV"´¿q"#$+r!
/¼)"/"$}2/－ 77 －  (.fg)p=19oqrT  

M+-B;FK0N{. &/ ! 0 )-?* ?*%% 

1 +%>A8'CEG<4F+A;CA&H#5DAYH{ PhH8hEHKSp<do sUH{ P=/V,l aXpPhH8h#][

EHKSpF

+H >9?4DA

 

!

aZFH8hEHKSpZ-F

D@ -&"><D;, (9>< 

| `73nm
aZF[}| aZF[}  

+-(>9<+=

!7E* I"*J +-(@64<B2!7E
* :F,A$I*AJH
@C<4F3







 

!]%9

1V
_FD`;#

!]%9



%"
 





7-=:)>13
D -59.
D?L' -/J:)L9.

_FC`
;#

$ 

GE?

!]%9

1V
;#.%9

E:)#
 C $=!IGH6 － 78 －_FD`;#  


#

1V
!]%9

1VS
;#.:

;#



%

&

?*
% %%

1V

%9

E7-=%A

0"W6/

   " !# $      

{ BpHcD|'bxvw}{ :Jp\\K{ \&*NO:{ MUH{ 5^UH{ !G`pU{ !G`pU{ % iQp0$LC{ fge4p `{ _2tWjsHR@{ ;6+oFks A?Iyzu



 




D4><N"!L'L%8- 8*+162=5:8O

_FC`;# 

%9NL.L'L8- 8*+162=5:8O{% % % % % % % % % % %





D7-=!2(*8<{ P>XPpZ-F 
  " #      !  #"!   #"!         !$" " 



'#&%
1

2

   #" $!   #""7 "7$ #   6:)98    



3



   #"
DBCE




 # !"$  



4<25:<



    #" %#&  
DBCE






4





H9 t}Ma(0, ¡@9$;5CE [;y>wu¡ !"A7

%!77=@<?>

88,EMPKON<>=)<4E
&#/2;-*C20>=9$20;E6B*=< 70!A1'"<;3@;-+



 



  

5－ 79 －

 

6   #" %#&    #" %#& > / 21%#.> 


  ! &    > / 21%#.>

4%SZ3R0:s! SZ#Wu". &)$(%'&/&  #  *,+-&

42;<'+41*%%%-2

7

   #" %#&    #" %#& > / 21%#.>

8> / 21%#.>

jZ1p [;  2'[;

DljI hTdgshTSLKf7U  6))>=<(%5; #38

 

?"s SZ#WS^\z8QnkvQJP  





9

   #" %#& 
jZ1p [;  2'rY O|U

10

   #" %#& > / 21%#.>  > / 21%#.>

jZ1p [; v R0[;6*N~:==HILJNG5?*:=(GDFE=.S*%Q%R< 4E

';7?/9%6!,>:.&&&

3<!"

jZ1p8 =e~


+;.62


7<*
0';)






11－ 80 －


1</



 %
$





$72.9
7(4&#/':3*) 5 ;"6-1405,+++12   #" %#&  > / 21%#.>

jZ1p [;  2'SZbB[;os[;A-Fm"1 4)'$121 4*-(3'"1&4)':=8<;0!)+0 SZ#WjZ1pJPB[;6*.

4% R0: SZ#Wi_.{s&`SZVG /Cc[;

;X[;s  

  

2'<]sq)

+



jZ1p8 =e~
13

14

708

'OQ4+P @.T[J>Y9 P(N \"DUPKQN<

@

;YTD:
3S4Q9'\!DZO;GHJ9FP#OI<J6P,\2HJ>YTD@9#@%K;Z?M=?9PUPK;Z?M=?5OI<J$\DZUPKQ;YTE]:
'PBOWY99B/O-X?P V1)@

CGLCJU9 

3S4Q-XP0&\*=UPKQ;YTE]:

15－ 81 － 
ªR¥[28)4:R¥28)4:ËiR¥¶¤\D





 Ê¸Ï
\²:/7$!¡° p<M[.6)*)-;4
\²:/7$!09(5;JOÖ C½¢»c¡°ØÐHkPsD¡ÌjFØH³¹p@aÐ^T ¦X\²:/7$!q¦[acq .8&9$d=  g«?Ößf® ÇR«?Öß~ ÙuÓ| {Ã«?ßz >Äb vUÅ ¨nÕ h¤ ¯` ÁeÅ` Ò ¦XPy%3,;:"91#4:Q·E×KxGE:¿E×K
Æ¥Ø:ØHjFÈ@E:WE

 ªlQ·E\²¥iÑÚË²B´Â     
     

3-0959.]¯Ë¡jkv"%¸~¾]¯)+/.
]¯|B¸[Q¨o]¯ÊÒÐµet?% z &%S ·X>ÜtAª @¾U´u ÝÀ\² %$µIÝ©m\²¬rµI¹Þ

k¸kÛ\²%9';ZY\²º¥¢º¸ 

P%&+3¼$'9-;+tw±w¾2)9&;#85 8Å¥?

 \²ºÉºx







\²?À:À¿uÅÝËaÖ£©¹Þ
\²Îd=ÝË~¤k¹d=5N¹Þ

N¶_­VL³IJ\² ?Y}






   \²Îo[ÝdÕ\ÜdÕ\Ë~ÂT[¹Þ\²ÁsIÝÊUsI¹Þ

E¶S¡£§¸tw\wÔÜZÍ Atw\wÔ]
$'9-;+

HsR¥,:( ¿©`­Ø±9¼¬ Ü p,:(Ý?Y-/;¹K[­d=



|¸±°È¥Z]¯ÄÚ È¥ %MP(%Q kÔRÙkÔRÅ¹NqQ kÔR¶|½726_ QkÔ¸?^aG]ÇÚÄR¥w>¶9z¶È~Í 9Å¥ÕC½¶9z¶È~Íc{Ef¥V¹

R¥Ê}M ÐO}MR¥_R¥ÇÚÉPy Ã»Ö9¦Ã9Å°rW< ¥P9²³W<

gJy

 R¥ÒÆÖKµ°rW< '0-!"ºDÌDFÁywz¶¨§É

hVp­®A×<Â<¯nÙK© &%

73<p" .L

－ 82 －

wn@«°H$ C{wnq¿Ï&%

|]¯f!]»d  ¤}°Ì( $&#(ÍXyi$(À%

!,%'#wR¥[Î($<nvR¥,:(UxÞß|½®|½j

e«TI¢ ¦l=V l JzgÅ ÆÄ? &$` ½ %W
cMD HA;º¬v»% N   ? &%

PÆ}ÀY*1,:-ÏÑ¶h×L£b 0  <nvy:./*$ÏÑZ¹dQ²³§¡x %
´Gs½(ZÑ\ % &#ÄÚu ¤}b'Â¯mÕ$(ÇÆ%~¾%´Gs½(ZÑ%W`¬%NØRÔÖ%ÄÚ
(#§%~¾%4ÈQÂ:tÂ> IÙBÓ4ÈQÂ:tÂ`tÂ> ×Î
IÙBÓÖ± rºÖ 
9IÙBÓÖÀH¥E0ÄIÙË² '#$$+#7
¸°Sf IÙs¦IØ  À %$3 
$"; )7!;È&69$M  IÙ|x ./%$
¡°AYM QÂ

y¹W< Roz73 .L



Ö¬Ë

 +)*&;mÓÂ

tbd\k$'#&%:g]>mqhQP &  :g]>h`j@; EZFVr&Ik -*×Î3$2)(:ªÆ®¥¹²I-*×c ´f:rºÖ± 
<Ôn±Á$';*).D¡¾T¿u: ¢¼p|}¹$';*).D¡¹×ÚX
@«b9×Ï
:\²#;'H¦Ø @«b]gE¹G~ÌÎ ×\qb


 

".-D
ÉÌ°SZVÜ:=,;$!;$Øx ÉÌ°S).#;*¹zÚiRIØÀ¥Ey[­:Ü\²¥i./64°S¢Ñ«µÜ ÎµI 
°S %$×_Îo=Êx ={­Âd=  Z[Q§¨ ¸= ¥E
IÙBÓØÃÐOq0ËIÙBÓØÃÐ
H¨ qbOq0ËÀH #"

$! q¯I ('~Kºzid Q¬i ('iI%'}N·Vn ¤mf}yO"KºgG¾VnHVn¬¡­e¸[²8i'C²FFV
$!   ;lpt£`;*´ µ0467.±
KºN·¹³¶p#U'f_Kº;Vn¬ª






ßÞ

¤}ÃM &%²NØ£rl¢¤}ÃM &%²NØ£rl¢ÜÂ¶Ý¨§ ¾ÈP,+ ¾(+ÈP F¯ PU
&ÈP,u¥'ÈPÎ+%Ö¬'hW¡-`m» +#¾  oC/52>BZ.7:B3<@ ÈP, ).7:B3<@!¡-`m» +ÅI!Ñ[AhWØÃs-l*Ù .7:B3<@-RÑ+©¬-R%×+SÚVÓ¢}u¥'ÈPÎ-¯¦.7:B3<@ ÈP,+^-W" e§H½}
TÍ+*

8 y«GÀK¸ &%f_e!¯E³ÅEIÆ = %Z? dÁ$O\w =µ¼'·#&%B¿#&%
y«r  {EI ¯E &¼!YLu'R ]¨s %

8p %WcGÀZ´$'S|q XP¯E &% eÅ°¥ÂA¾Æ!A<"¯E³% "Z?­s'Ã {EI XP¯
E &®@·O8YL!-.91(/3YLF &%
¯E³Çt§Us8iMs¦s8Usa;¡CC}hWp@§UV"%²RP/9=C1>Al³°¢©¼
ÛB|½ 1R|½ 1RL|½)ErX@Ê9Ê£Â |½Å¥,_

¯hv


 ºUÖVÐ+*nhmBÁSÉ F©º%ÁS+

8 y«GÀK¸ &%f_`*0+6
9>)249,57 f_ :o`¯E &% $)249,57u'R]¨s %&Ü")I!Í[BcW·'*/9=C1>A,TÍ*

8y«¯E &%jGÀW %^¢T¤'Y`*0+69>
)249,57 ¯E &%Qm'kL% ~©"%)249,57'F·%

DZ°¢©¼
g_Ub +µÈP+" Ub +µÈP tÜwn Oz­W146±³ÈPWac«Iº¾Þ¼yb  Ub +µ),+wn )9?0=;c« r²(+µ
AÛT]¾fM$)Cªi Âª£«XNÄ²W( Êªi £«Q+Ç«vÔ¶Ý `¤ +wn Ê`¤Ý&,(+µ&¹),+9?0=;c« r²Wac«Iº¾Þ¼yb Ä),+wn Ub +µÈP×Ð|LeÍ-½&Oz­W146±³ÈP-É$+－ 83 －

¤}ÃM &%²NØ£rl¢Ü¯¶ÝßÞ¤}ÃM &%²NØ£rl¢¦Vn
KºN· ('f_+1,59r#~&
*x§{¯I' *~' %B^=t*`;' 

¼£(%UI°·:i@;Y' *A<«*29/® (IM'f_(sX*? ' Rj$v¹½D'|hx§{!;½D'Zb8Z¥aI$g>H

¯hv


 SÚVÓ,+wn/52>
B F¯

Kk®HÄ

4 & `~cA &%
oud]N|
`~cog&A &%8ex 
Iv;mP
%d<hD4HC!,.50(/
3UO$ 
hsuWb' »LTx§\E!&:u]¨zuPF©kO%o°u]J'­e¸ ¼W 'f_o°W¼#(%'w #¢
&('

pD+

4 
ltz Mqfn^T &%`~'Fa %GX`~#py]wZ> 6'8JE6?i_ % % : GtkV%-5,+51R -20)*(@rj' 9 %[Y% {$ @r &%QKS o\'%
oTBGtgc `~cA% 'ex  &"=hI
v;mJ}]L7 %



 %ERÔXy*7=-gÞT°Ár &%rM"%RÔXy]K>QMA =d5SVU F;=d5Svc'[MAz¶$&Mbc(hJ0 ?£Ã\  I0:./*
$ZAx a¦ $6+e?£ P
nWvh ; ÙJ0Q®Py6.&gJyDS %ÀY"§O.9.<!^Mr2Â  %$¥EØx 

7Ï

8:Ø6
Â

¨«Ñ¥
¶y¨«

°SÎuIQ

BUÖVÐuÄ
%DsÒY¶yÁS'*`}BrX},ª $(+*')¯¦^zuÄÈU+*ØE­\²¹°S¹IksIkeN153R¥[h£Q/3 5S9c!^Mr

B×¦¸IÂd UÖVÐ')ÁSÒ,¼*`}©Â,¬D×Â{¹
, NÅ~´ Q¡ *M o')q¤Æ *BUÖeÊ+nht¶yx ) ^Ô+*
$;.C8:50'*k,²)Ë(}*Ñ¥<@32 O¡ 

BLK ÂuÄ»jZ a¤­»j+"UÖÏ¡uÄ*­lYiJ°#IR*"8/6 ^z¤¡-<?,LK UÖVÐ,*
gµ^z Î¡+*ÎoÒ=xQÂ

/[*c

1J0

w\u

 

s=


»Z´

¿sS

w\u¶¹WªbWc£x,i
f|SO7

~l












Xi

zeW

~l

TB

wÇ

nK¸

[

¿N
n

CÎ\²IkD¡¦BUÖVÐBUÖpP¡¤Ú^zuÄ(Ô)UÖP¤¡*   UÖpP¡¤Ú^zRb )»jÑ¥!._ ' Ía¤^zßa¤Ó,*^z)
 (DSÂ"+ %<Gz)Ñ¥._ *]s¤Ú^zßDM¦UÖVÐ,_8
+*^z)UÖeÊ!);(+`F_R

BÑ¥\G b\) 1a*,V" Ía¤^za¤Ói2,0*'*4K ,gµ*R¦^z,9¿*¡gµ},5'*

°S<¥Ef

BUÖP¤ * 27 3)H»j + "UÖp¡%^Ô+* (~´Q¡M,[*





¯hv

ªlIÙs;²ÞIk»Ý73 ))&(,,,'# ' %( %,$"%(!" +!( ! *!& "% &*"!)!%$!""A.L

vHy/
U9K"n{YO

B'*S<F (`,NJgµ
,i



s=

 

2?_D1J0 e !:G6R

e

Â

f

ªÆIkIÙNÇ qb^«j¦ÈÈ  ¦À× 7
U Îß°S×:g×  À#;'NÛÌk 0QÀ %$¥EµI < IÙs;²ÞIk¦
 CÎ\²IkÒx²ÞIk¦Éa CÎ\²Ik^8Òx²Þ
IÙs;²ÞIk
IkÎ ½¦»Ý 
¶ n±/[Oo)/["xDÂW(Y-+

NØRÔ0*6;,

IwÇBwÇ{ÁSÙ
S W4
I_¾¢¶yÁSB
5IM{}8^ "a
f|
Ó

wÇ

Þºx¦nSNØpJ©¯ÛXy¤LÁµ<x##'7/7$..K· JÖ¹Ö¹Ö1 ¥rºP
..cD JlIÙ7BÓP ^«j<QÂÝUBÓ=×D¡Êx=ÞW =Êx*;;¬¯=ÊxP^   =qJ=Æ th?=  

1J0

I
Ù
B
Ó

Â

±
7C4eØ
 ß7C4eØÒY(,V"I´ DS*ÒÝcd,Þ* ßÒ¯G{$(+*7C4Û¼+*A #?WQÛÔ(I´Å+$LQÛ­ÁS,O*$LQÛ*nh/+*`=Ds^,¿s^,T*­,À*U)*%A,7¡*nh%hC¦ÀuÄ,¿s*%*BVÐ{DsÒ `}BrX}Ó*7C4,eØEÒ¯G{S,ZÃ *È|ÏS¿s gµ*Ü_·Ý4*2Xyµ(FD NØRÔ(% a¹XyÓ© &%

>°#h2

®¦
Û
U9KND
C2Kn{

w\s=Ý®¦ÛBÞÀ¦Û
U9K(C2Kn{7BÓ×UÌ[À
%$¥Ed=BUÖeÊ++UÖpP¡¤Ú^z&¨«¡Ì,Õ ~´Q¡M ^Ô+*IÙNÇ×

5S9c!^]G

¨«Ñ¥
¶y¨«

¯hv


À

w

ßc³Z a¤­»jLd ÔKÂ^z,]¡VÐb\¡+Ù )
Z a¤v£%³Z a¤ *^zÎ¡±=%³¿¾* 1¼*Òx²ÞIk¦QÂvtIÙBÓ¡xB]s¤Ú^z ]sm ©UÖVÐ,F6gµ}*»j %¡gµ*,©#DSB@s<@32,© XY*D¡2e^«j¦>ÎB]s¤ÚÁS¤Ú,=C2},&:
* xI9?C,O*
UÖYÁS %"*- E2*－ 84 －

ÞÞ>w{¹c>(ÍÎ18:;-ªÅÂ¯mÕ^Çr%GÇIIX

nWv²³§y¹dQ  ByZ)478CTCT;rb :$<b <nvy¹W<  #dQ`/ Å¥,_<41  Ç«vÔeÍ¢}+LÍN-G{°LSÚc«eÍLSÚc«²Õ´·EÆ¸+ Y¿, LÍNqJÒ )   °L~Àp8=@4+ÍÌ S,+¨§F+Ç«vÔeÍ¢}+LÍNq-ÁÏ© )x d\j,+JÒ+(°L~Àp8=@4+ÍÌ-S" +

¯hv


 °Í¡°YLQM ¶E^¯duI 

QÂ

&69$¾½:Ë²pÔ^¾x E¾
F#3 
°Í¡°YLQM BÒ ¶E^¯d&69$¾½uI °ÍÒF
9%9"(Iw :Ë²pÔ^¾x E¾
FÊª¾½ °Í¡°YLQM BÒ
¶E^¯d&69$
¾½uI 0Ë
:%0;"-9×_ ¾½m
^Û× $"; )7!;
È³ ¾½qn±



¯hv

(589#!Ik
:\²¥i²NÇ<"E¸=H!IkIÙÒ¸= FÖ#;'=
'#9$<kØÀË²p
Ô==Z!§¨  ÂZ (589#!Ik# À§¨ ÂZ[QÂ©LOË²pÔ=¸=  
=?!QÂ ÝGß=#;'È1  Èqb
Þ
|U!QÂ !QÂØÊ =Jx  «j:¾ K= G
qb
E!º ÂZ§¨ ¸= Ë²pÔ
=Ik: ¦
ÆXZy
ÀÊUwZÂZ§¨ Æ =? °S®?rºË²pÔ=x !¥E<k qb=
ZØ °ÍÀ D¡Âd=¡
×9%9"(NØRÔ£¹ ©"$wÉ{°
¹c>({ % z &%Þc!^;.bc( ÕYÒvcMr<µ 
=8D y¹ÜPy¦7 Õ*ÝdQ V¹yÎ§-
V¹y>  !^ÕHÒv²³L£V¹c<M
rONÓÂ 

c0467.Vn%'S¯I®?rºÀÖ#;'NÛ

IÙNÇ
Ý UÞ

$={x(589#!

t£`;_)S¯I-/13¿ À
®?rº

IÙNÇ
Ý UÞ

¹Âd=Ø #;'NÛ¹Âd=Ø #;'NÛ

Z
Ý%U¡Þ

RÔ{NØ>XyÁ

¹Âd=Ø #;'NÛ



¯hv

IÙBÓÖ¾Ð IÙIk=ª 0µ:IÙBÓ<xØ6 qbÖÃÐIÙIk=ª 0µÂÝK Ö ÞZ[ QÂÆ tÝ©²ÞQÂ  IÙBÓ=4Èd= :BÓÖÃÐ§¨H qbIÙ=IkÊ   ÂZ[ QÂtQÂLO 
IÙs;²ÞIkf BÓÖÃÐ§¨H qb<
µ[ §¨HuI 
H§¨#;'¹W(589#!
Òx²Þ[$4;Ik


Z
Ý&U¡Þ




－ 85 －

!

$#

'(&

!

   +/*   

  






:U·C;Gu! cÃnªfGuÔÅwÈ



!

&3B

)CAD


?]$WS4 <"Jy=D"0fKUz
6 [de2M/' *5"0ypu#Q(#>%
5#Jy=D#vZ#aE#ic.G>2U*0&_T   

{x2HC!.P5"0G>$o|"U3/
7"

+P5"12M0

*0-vZ,@n\"  

#-!q~"(FgbsT.Il29!OLh8ro"`t0kN?

!M/^
0;2mjG>%YfKU"V

7"M/^)&:2`t0`t:
Jy=D"0G>%YfK2X|0*#vZ,@n\%
7"0FB#w}G>#AVR


)CAD

&3B



:%7G

E® ²¡ Q@IR;vjX§e\ ^¢S
 ßs Ù= 8Q¢THR;`>oD¢c 0&4



'=

h,:q%+

;xw¢)5*?+#Ü-m<

/

s

s)

{°Þ%o¤*$;<Ò2%xl-4k,'(¸¢)5* ?

ÂP g 6:­x>m9¢THzS9Ç­¢M9M9zS«E ÛL ÀC l°¨"R;Ö XA?
<r ÕØ 8Q¢THR;­q½ ¦¿ ¶Æ¢cXA?

$4(.>5'N Ò¼ 77Z - */3,%045,%$\Ú{¸aY}Ô-Ñ},(q%+|Î<m"(Ê#:**5, LTIQGC6V²ÇÖ³Ó-¿"Õ&ºÁ Ê [BtR;6:±9 XA

%Ä0-j´-%4-<Ðz~#1 ÚWdU,V¯ Zi $')5+2$~9B)5* ?
 « F_7Z7ZyxZ¬¢¯ {¸JO ¾@ 8Q¢THR;8Q#¢)5*Üvm!;%

.> <,:9;!)+# 37-=1268

XA ¢c? #(.1vjX)5* ?

Üvm!;%*<Ò2 É½Ëer,:ad | 8Q¢THR;6:¨¢TH\ XA?

yg §<Û#:%4 w-o¤,'({°<`&%

E ÊÌ ËÝ×7ZZM¨Ik XZ{¥ {¸ rP ©= F_Üµ¯7Z¹}Yb¯ZÉ³^{¸yg §<Û#:Ì8 ­,n,{°#1HP,'(PK ¤L Óh8py ´y?
P: ÏL ­¨\ oD\ XA? ZoÍ]Ü V|ÎUZ3<¨#:er*). ½Í©yg,:£M ÞÐ =»BtR;6:¨\ `>WD9 ´9?

ÎÑÄ ³?´³?Ü V|Î*-c,'(-§,'({°§<:IF-Ñ},'(). É½Ëer,:nIFNE-§

<§"%½ËÃ-yg ¼Å,:ÙbIF-¾»¸±,'({°－ 86 －



'=

?+

#

/



?/0"?+½Í©yg,:IF-§,'(

#

/

-§,'(

iep~cO)+ K?A½Í©6{½Í+-Kn+er,:-§,591_-¡¢5Â4]¦<fß%IFª®¯pBSHÓ-Î¬~¯ÍM.GJ),,'( 6[)&(5_X%*W:5-,#1

IF-%4-i,'( _<Â4%AMJ?T)-i 2% ½ËpBSHIFÓ-IF<

u)-¶µ×-Ì8 [ ¥=KF,7:i6 º[IF<#:Æ3<

_IF-®?,. /È¹). ÉØ½ËIF-AMJ=@J,7:¡¢<Â4%·^n+SS)% =@JB,*&%++*+E(FSÓ-1À5Ò2''- J\Ó--3;5Â4(Nm#1

@Y¨"(:IFNE62Lz¨#:@_N+-IFNE0->P5Nm#1

j"( IF§-SS<Rk"%?&.?T¯
-g7,'(yg,.X+º[c-AG5Â4 >Pk;,'(-{°<#1

6<+½Ë-}E ½Ë-(~ ½ËEFG)-~kMo-g7,%&(-pG<¡#1

,'( n+-%4-HEJIF¯[qC
½Ë*

É½Ëer-nIFNE-§,'(½Ë-§,'( RI>=5§"%Xt0-ÝÏ¢g¯ 2% ½ËE46t8_,,=#:<%Ê°M0$E,97;%Lr-tj-g7+-Nm

5jr,7;:1

%\) º[IF<IODGJ#:Æ3£8;: ^k AMJ=@JÁ«5)9 À'=t8_"6#¾»<¸±#1
-`ke:[-qC¯UZ3<¨#:er0-

-C.@&RQ,-§,'(Ó<§"%x6~aY):UZ). vcer,:-ygQ<£#1

yg,'( -E!E<tm"+8 s¯):<Nm#1

-§







'=

?+

#

!

/

½ËÃyg-%4-ÙbIF-§¾»,'(º[c;<£"%½Ë-F 3;,'( ?&.?T<SC"Q¬<:Y~#1 ­,^IF,'(.Q¬+%4 Xo)F %)J-yg`;(8AG):?&.?T-SC,%&(. ½Ëu-}D,&%5-*+:7#1

   

$-y9#1HP,'( @6I>M.'T *&%dn,'( É½Ëer)$;;-=S"/#,<#:4c-1+wn{°¯apG-Nm,%&(.

  

BX-ez5¡#:*5¯ .*D, *&1%;2),Þ% f,'( }5|~HÓ-]-h{YÓ)Nm!;(:5-À/pBS
H-Î¬~+5:*8 xl.­,
**#: À/ ½Ë vcE40-yg §,­~"%pG,'(n,{°"(-g7,%&(-pG-¸6yg §,%k

+-{°<`2% Þ% f- V,l3):5-,'(.jb<` Ðzn,. ½Ë-F3;-?&.?T65u ½@If-^9²m-fV" É½Ëer-nIFNE<§"%yg--E!E-TU,'(Nm<yZ#:



AD84

!*

-9

.$60



,2



S-IF9P;8 S-IF3"<W1!RTU6%] 9PEO:'()&^Y> C=+B[AL$!G?.$#



VX07
bHDJIFEO:D _@ + / KH^%\Z`HDJI
F %,-M2<450a^E:"QN"  

#H.e5?GXCFLE!#XD.L
A780W,Z'$)<XFLMK&"('$NXIG


 6 X ##=X2U+X A7af_X3% WJOTVd^\YX1 ec`]af_YX1 G

2!S /S &H1E2!R OV+ S0*H
G "!R OV+ S0* A



 









6;!WG "MH6; S59QS%WC
6;!S$7RMPHKULNT W#TV2!-S)8

 


  

    

2

－ 87 － 

 -ST6 '$X2U+X ;@ e9 WPQZ/X4 9:>W,ZEB/X *R G

 

IF "!JSDHB(Y.:AS=@H?S>(H<34,R'V!$7S@ A

! 



 

,/:+.*-07459)#!8130769  $  )#!& '($ "%

>.6@(;5<F1E'"







1&



;4)

BZX
*uv¹ÙÀÛ»±Ï
WN/(9:87'

= P/3Gr#LQqdbn]
%{ <ixfprqm Qf_V[
bn1Ohlo], <}|v#L F+[
Q<}|phn4uwyx>=v$K}|qmbn-9{Mb]"R}|{%qhn<bx[r'5Gqmbn {Ci^§¨* u©ªv¹ÙÀÛ»±Ï*546EBG !85;46%p?4671&9n3=A%q

{6<hl>3rY?~BEqdex}| <r&(+pS\) qUixBE
2?+96=;),5>70<j(k:l8tW4e3^[ Lhg E\
moC Z5<bF ^}.V9`0O

      0'$?

"@"$?-azjn]gyl>%rts"<c JKz6}$P{tJKTQopn1%;zR~} r "<c ]AXz+U{<bnMc= P/3GrY?~s A2a_BNI*)
BEGsr_{Tpix:D~"UYDK
3*@AHBEqZix9*X` ][s#SJKyy -?/xzD
!.WD@~: @~I7;2@si(4=?Y{}'- &,CFrV<rNqmbn-9qi(4=?
"'?,%(*:78>; 6*:39>
.@)541/<=+{Mb]krJ0qmbnAix^
kf@Bw7 A>Md|}u'-%!



$!#;.6=-@!2A#$&) 

#

!(':=CA

8H05-hkil2 KNvY
"

!



"









!



$ #%"

{6<hl>3rY?~BEqdex}|«y}m'¬
?
g] b"
q®¯
 0¡
q U
l[ £
G¦ j
^e {
c 
>[ £



 

&'%$#



"!
BZX
*uv¹ÙÀÛ»±Ï
WNBZX
*uv¹ÙÀÛ»±Ï
WN<r&(+pS\) qUixBE8!k¯ ´ÖÊ·¾ÖaE z F
?Ú1ÚA^iHM D/,~­°y}¾ÙÁÛ y}SR¾ÙÁÛo%nn5 5w+iuf)¾ÙÁÛ 8n y} 
6/Ë³ÖÏaE z ÐÄ²¶Ö»½ÃÏv¾ÙÁÛ
( r[Ks5 5Üz+iX[ru»½ÃÏ@d,~­°y}¾ÙÁÛy}M uy}v ,~,¤uy}¾ÙÁÛ,C t¢ T9|u|
w+iuf)¾ÙÁÛ =uf)pdy}M  y}'$<1313¢I.3y}| VP
+iuI.»½ÃÏv¾ÙÁÛ n³ÐÛ¼

mmc?`nQÝ)3

<:=^SVd,F@+f

14XYL6

14XYL6

#G0_B:=^bd:=
#SJK!

#SJKHG|x

14T$Wedglkn



PD%_5-M_jli

14

LZ(^lokh>ZJMC%<P

Q;7:=_E>T"URB:=\XZB:=-M\\a^& 46nH/ScOWTe .'n@YX[b $Mlok[J20M46H/[)+[Nd#\-YdM_U:`gU)+aRfe=uf)pdy}MO5-M[J ]jli T *dR/I7%_5-M_jli 14

.590f«µÌºÛÈÛ¬ox14Lo|3oxÚoko;uf)7`nÍ×¸ÔÏuf)7`n5
I.2' ;z+iX[uf)pd#:_ &¥,~­°y}¾ÙÁÛy}M uy}v y}'»ÓÉÙ ±ÙÅØÙ ´ÖÊ·¾ÖaE z y}v ¿ÇÔÖÎÇÛ¼ÑÛÚÂÛË´Ù¼Æ±\h´ÖÊ·¾ÖaE z d[ ÄÛÁÎÇ¼ÐÙÅ´Ù¼Æ±J Y!
6/Ë³ÖÏaE z ÐÄ²¶Ö»½ÃÏd ÞßÀÕÒÛ»ÓÙ OÎÇÛ¼ÑÛ«;¬w+iuf)¾ÙÁÛ

!

,I<M46H/mioj7Zcd(!$  " %  
#&')  

!!








  3Usx]z%ElGlmAa_^)*,.!)1'&/(1%El8QPn~e)*,.
ualGogN%T Fq<{04Bavf8%M %9 cR
GlmA-1+Hk:`I$"#cRo[Ou%JSb#Zx;
%T #e |O#ukQ*,)#! 5/0571 493692o"Z@,+)#)I'  
 WhW"  GogNr6l$  @jZI>Zt=}i "72TYX|
 WWGogN;Kx L D?DCa
MON:4,=>+!#.<&F80J 9E($5C72A% 
A $6BE(=31
MFL'= !#A*K6@)
-G8M" 72AN;1  5C31N

MPN:4,=>+!#.<&F8/IH :4D?720J 6BE
(=31
MFL'= D?72*K6@)
-G8M" 72AN;1
 5C31N@jZt=

>Zt=

  Ip#`yV\w5d#`    

ev">i+493o#n:r&#Z@8mG%Xwjz.I'JiDi"+Tro#HV~C"Q*,+ " X
wjz_" #d("RjzrbY{["Kx^+
ev">i+493o#BSlA#(#~C!ph?$ <E#cqos-, \stFn`#"tN+jz{[#BS#Kg"Pf;{[=W,+
~C!phs-,+ " BSya_"jzrbY{["Kx^+e}+]M#ukUL)I(BSlA#(#~C!phs-,+－ 88 － %"－ 89 －

  ݆ 
ˑ‫ލ‬峛໵ 00. %ࢊ‫ָׯ‬峂峣峢岶屎島峭ʛ୊෨ 峤峺岽島峭ҫྏ‫حؽ‬岅層屫岥ҫྏ峔屎峌岈ཤ‫༽׈‬岅屾属岀ʛ岅ଲ屳岥ҫྏ峔屎峌ཤ‫༽׈‬岅層屫岥‫ۂ‬ֆଈ岈‫غ‬ଶ岂՟ୌ$"'!

 峤峺岽島峭ҫྏ‫ حؽ‬岅屾属岀 ֋൅岈Ҳൢద岄峤峺峈峆 峔屎峌岈ཤ‫༽׈‬岁ഓྂ屳岓屧؏఼‫ݺ‬ਕ৚ๅฯ‫ޤ‬๑ ྛཀྵࢨਓ ৶བ੓ฯৄ ՟ୌқࣟ岂֋൅岅޴屫屹峔屎峌ཤ‫༽׈‬岈ಊ屧Ҳൢऀ஄๑ਕ ೖຌҫྏ‫ۂࢊحؽ‬࿊߻ճ峤峺岽島峭ҫྏ‫حؽ‬ଲ# ฯ‫ݧ‬ଲԢ 5&# ෯कࠬ䑷     ஊ֌೟ৄ岂岈‫༽׈‬岒岈‫غ‬ଶஊ֌ট೟੏ౕ岈‫༽׈‬Ն೵੓岂峔屎峌ཤ‫༽׈‬੔ߨॽ࢛䑷     

峤峺岽島峭ҫྏ‫ حؽ‬岅屾属岀      

ਏஇࢩԋ ֋൅岈Ҳൢద岄峤峺峈峆ʛҫྏ৚ๅ屦චགྷ岄峆峓屎峅峔屎峌फॄ屇ָढ़‫ڂݜ‬੣඾֋൅๑‫و‬੏ଲԢ

ࢤ൤‫ޛ‬ଲԢ屇ฯग峔屎峌फॄ屇‫ڂݜ‬屇֋൅屇๑‫و‬੏ଲԢྡজ඲Ճָसࡃ岙峯峔峸

‫ۂة‬ҫྏ‫ؖؽ‬

ָस峔屎峌

৶བ੓௒ࠬ

峝峷峔屎峄峴崀
峔屎峌峓峆峕峔屎峌
峫峸峎峦崀峍屎居෵਼‫ؖؽ‬履岣岈峔屎峌岁岈‫ৄݗ‬屦‫ٽ‬岛岣岦岥屆գ‫ڊ‬岅ட੷屯岦屹๴୉岄ҫྏժ଀岞‫ं׳‬
峔屎峌岬༽属岥岾屎峆屦ଡ属屆գ‫ڊ‬岅Ḭ屽岀岈ಋқखಚ岉ೋ山属屆

   ")251༽岈ָस峔屎峌‫ܩ‬କద岅峝屎峅峴崀岯峐峤岬ߨ屠屹岛岈‫ڂݜ‬岈࿰ૌ岙屦චགྷ屆島岱峢峂岱岼峸ʁʛ ೧ਏஇࢩԋ岈֋൅岁岉居֦峆峓峐峤岁居෵਼岈ҫྏ‫ؖؽ‬履岣岈峔屎峌岬ௗ‫ؔغ‬岅岩屹岤ཤ༽屳岥චགྷ屦屜岥屆

https://www.igaku-shoin.co.jp/paper/archive/y2022/3458_01

䑷  ੣඾峤峺岽島峭   

ࢂߡ ֋൅岅࢘岩岦岥峔屎峌岈ྪพ䑷        

峔屎峌岈ཤ‫༽׈‬岁ഓྂ屳岓屧؏఼ʁ‫ݺ‬ਕ৚ๅฯ‫ޤ‬๑屙ಙ໌Յ޽৚ๅ屚‫׮‬સ岅‫ݺं׳‬ਕ岬ࣟพ岁屧屴居履屾෰‫ݫ‬岁屧岄属‫ܙ‬岅Յ޽屳岥屭岂屦‫ٽ‬岛岣屢岥屹岛居఑‫ݫڛ‬岈ҫྏ‫ؖؽ‬岅層属岀屷岈ࣰແ໚岈ଲԢ岅屾属岀‫ݸ‬ֆ屦屜岥屆ˠಙ໌Յ޽৚ๅ岅‫ٽ‬岛岣岦岥展ಝఈ岈‫ݺ‬ਕ岬ࣟพ屳岥屭岂屦岁屧岄属屖岂属屠གྷ݇岉居ঙ岄屩岂岜居Ҳൢਕ‫ٶ‬岍Ҳൢద岄ࣆ‫ंۂ‬岈೵ྙ居घ๑౵岬‫خ‬६岂山岀౲֚৚ๅ岬‫ݺ‬ਕ৚ๅखѽࣆ‫ंۂ‬຤岉ಙ໌Յ޽৚ๅखѽࣆ‫ۂ‬ं屦௪৙岈๏๑岅岢岤ಝఈ岁屧岄属岢屠岄য়ସ岅屳岥屭岂岬‫ٽ‬岛岥岜岈屆ड़ఱʁ୊ յ ҫྏ෾໼岅層屫岥Հ໌Յ޽৚ๅ岈ฯ‫ޤ‬岂ཤ‫༽׈‬岅‫ؖ‬屳岥‫ݗ‬౾ճ ࣁྋड़ఱʁ޲࿓Ռ‫ݜ‬૱‫ׇ‬ๅࠄॽʁ岬‫༽׈‬山屹ҫྏ‫حؽ‬岈֋൅屇‫ڂݜ‬岅層屫岥峔屎峌ཤ༽岈ࣰସ೼Ѵ岂՟ୌபड़岅ࣁ屳岥‫ڂݜ‬䑷     屙Հ໌Յ޽৚ๅ屚Յ޽岅岢岤岕履岈৚ๅ岂ল߻山岄属‫ݸ‬岤ಝఈ岈‫ݺ‬ਕ岬ࣟพ岁屧岄属য়ସ岅山屹৖߻岅居ຌਕ岈ಋқ屦岄屩岂岜居ཤ༽໪ద岈ौೊ岄รߍ屦‫ڒ‬༲屯岦岀属岥੏ౕ屆‫ع‬岅ҫྏ‫ؖؽ‬岅ฯ؇屯岦岀属岥ҫྏ৚ๅ岁屜屽岀岜居Հ໌Յ޽৚
ๅ岅Յ޽山屹৏岁ཤ༽໪ద岬รߍ山岀居ཤ‫༽׈‬岁屧岥屆ҫྏ‫ؖؽ‬岂‫ۂة‬岈‫ڠ‬ಋཤ༽岜Ն೵屆ख岤ѽ屠ҫྏ৚ๅ岅岢屽岀居‫و‬੏屦ҡ岄岥屆৿屹岅Հ໌Յ޽৚ๅ屦居৿山属峆岺屎峭岂山岀‫ݗ‬౾Ն೵岂岄屽岀属岥屆   

ཧ⪃䠖➨䠒ᅇཧ⪃㈨ᩱ2
䑷  ⏕࿨⛉Ꮫ䞉་Ꮫ⣔◊✲➼䛻䛚䛡䜛ಶே᝟ሗ䛾ྲྀᢅ䛔䛻㛵䛩䜛ྜྠ఍㆟TF
      

－ 90 － 峔屎峌岈ཤ‫༽׈‬岁ഓྂ屳岓屧؏఼ʁট೟৻ࠬ岅൒屠৶བ੓ฯৄ 峔屎峌岈ཤ‫༽׈‬岁ഓྂ屳岓屧؏఼ʁਕ岬ଲে岂屳岥ਫ਼ໍՌָ屇ҫָ‫ڂݜܧ‬岅‫ؖ‬屳岥ྛཀྵࢨਓಙ໌Յ޽৚ๅ岂山岀岈఑‫ڛ‬岬ण屫岥৖߻Հ໌Յ޽৚ๅ岂山岀岈‫ڠ‬ಋཤ༽岬ߨ屠৖߻ˠ展‫ع‬岅ࡠ੔屯岦岀属岥岜岈屖岅֚౲山岄属Հ໌Յ޽৚ๅ岈ཤ‫༽׈‬岅੏༁屦屜岥‫ع‬ଚ岈ҫྏ৚ๅ岬༽属屹੓೵඲Ճࢾ‫ݩ‬岅屜屽岀岉঴ྫ岉న༽屯岦岄属౵居੖ཀྵ屦਒岛岣岦岀属岥屦居৶བ੓֮ฯ
岈๏๑岅屾属岀෈໎֮岄෨෾屦࢔岥屆րਜ਼‫ݺ‬৚๑岂岈ଲԢ屦岂岣岦居Հ໌Յ޽৚ๅ岂山岀岈ཤ‫༽׈‬岅‫ؖ‬屳岥੖ཀྵ屦‫ؖ‬࿊‫ؖؽ‬岁਒岛岣岦岀属岥屆ड़ఱʁ޲࿓Ռ‫ݜ‬૱‫ׇ‬ๅࠄॽʁ岬‫༽׈‬山屹ҫྏ‫حؽ‬岈֋൅屇‫ڂݜ‬岅層屫岥峔屎峌ཤ༽岈ࣰସ೼Ѵ岂՟ୌபड़岅ࣁ屳岥‫ڂݜ‬ड़ఱʁྫ࿪೧屇 ೧‫ݺ‬ਕ৚ๅฯ‫ޤ‬๑岈րਜ਼岅൒屠ਫ਼ໍ屇ҫָ‫ࢨܧ‬ਓ岈րਜ਼岅屾属岀䑷        

՟ୌқࣟ䑷  ᶅ峔屎峌ཤ‫༽׈‬岈Ӯକ੓岈՟ୌ• ָढ़‫ڂݜ‬岁ಚ屹੔Վ岬಍ड़屳岥屭岂岉岁屧岥屦居ָढ़‫ڂݜ‬岁岉੖ཀྵ山屧岦岄属ট೟৻ࠬ岞ࢤ൤‫ָޛ‬स岄岃岈ଲԢ岬‫؜‬岛居峔屎峌岬‫ܩ‬କద岅ཤ༽屳岥චགྷ屦屜岥屆ָढ़‫˲ڂݜ‬੣඾֋൅岒岈࿊‫ܠ‬ʤ಍ड़ʥ居峆峭屎峇岄Ңߨ岈峆岺屎峭岈੖ཀྵ屙ึଏ屚‫ݺ‬৚ๅ ָसࡃ岙峯峔峸岅層属岀居ಝఈ岈ड़ྙ岬ߨ屠屹岛岅௒੖屯岦屹ॴཀྵ屇‫༽ࢋܯ‬岈‫਼ܐ‬岁屜岤居౲֚峞島峮屎峌岂ಝఈ岈‫ݺ‬ਕ岂岈ଲԢ‫ܐؖ‬屦ഋੳ屯岦岀属岥‫ݸ‬岤岅層属岀岉展‫ݺ‬ਕ岅‫ؖ‬屳岥৚ๅ屖岅֚౲屳岥岜岈岁岉岄属屆       ֋൅岈峔屎峌ཤ‫༽׈‬岅޴屫屹ಊ屧ᶅ޲࿓Ռ‫ݜ‬ʁ 岬‫༽׈‬山屹ҫྏ‫حؽ‬岈֋൅屇‫ڂݜ‬岅層屫岥峔屎峌ཤ༽岈ࣰସ೼Ѵ岂՟ୌபड़岅ࣁ屳岥‫ڂݜ‬ྫ࿪ ೧ౕ居Հ໌Յ޽৚ๅ岈ཤ‫༽׈‬岬૟ఈ山屹峆岺屎峭層岢岍՟ୌ屦੖ཀྵ屦岄屯岦屹ժ‫غ‬ద岄खૌ岙屆屯岣岅居ྫ࿪ ೧ౕ岜居ࣰ༽ద岄岹岱峖島岱崀岬੖ཀྵ屳岥खૌ屦ࡀ୔屯岦ਬ਒஦屆಼ֵැʁ࣏੊େҫྏ‫خ‬൭๑‫ݗ‬౾࣏੊େҫྏ‫خ‬൭๑岅屾属岀岜居ಋҲଲল‫܊‬岅‫ؖ‬屳岥‫ܩ‬କద岄峔屎峌఑‫ڛ‬居༂ࣆ໪దཤ༽岈屹岛岈峔屎峌岈ਇਜ਼੓֮ฯ౵岅ଲԢ屳岥屹岛岈࢕ૌ岙屦‫ݗ‬౾屯岦岀属岥屆ᶆ 峔屎峌఑‫ڛ‬घକ屧岈՟ୌ• 展ಙ໌Յ޽৚ๅ屖岈‫خ‬६屦໎֮岅岄屽岀層岣屴居 展ಝఈ岈‫ݺ‬ਕ岬ࣟพ屳岥屭岂屦岁屧岄属屖岂属屠གྷ݇岅‫ؖ‬屳岥մए岅岢屽岀居఑‫ڛ‬岅‫ྂۦ‬屳岥ࢬઅ屦屜岥屆• 展࣏੊େҫྏ‫خ‬൭๑屖岅‫خ‬屿屩居展ಙ໌Յ޽ҫྏ৚ๅ屖岁岉居峔屎峌屷岈岜岈屦րร屯岦居‫ڂݜ‬໪ద岬ຮ屹屯岄属岾屎峆岜૟ఈ屯岦岥屆岘屹居ժ଀峔屎峌岈खѽ属岉岘屺ࣰྭ岄属屆• 展Հ໌Յ޽৚ๅ屖岅屾属岀岜居‫ݳ‬৖岁岉居ࣰࡏ岈Յ޽घॳ岉໎֮岅岉岄屽岀属岄属屆ᶇ ৶བ੓ฯৄ岈՟ୌ• ҫྏ৚ๅ岈ཤ༽໪ద岅履岭屦岙居߻ཀྵద岁履屾ࣰް੓岈屜岥峔屎峌岈৶བ੓֮ฯ岈๏ࡨ岂岉Ձ履屆岘屹৶བ੓௒ࠬ岈๏๑岉ʃ屆ड़ఱʁ࣏੊େҫྏ‫خ‬൭๑岈‫ݡ‬௜山岅屾属岀  䑷         ֋൅岈峔屎峌ཤ‫༽׈‬岅޴屫屹ಊ屧ᶆ䑷        

 ஊ֌ট೟੏ౕ



ਕ岬ଲে岂屳岥ਫ਼ໍՌָ屇ҫָ‫ڂݜܧ‬岅‫ؖ‬屳岥ྛཀྵࢨਓՀ໌Յ޽৚ๅ岈ཤ‫༽׈‬岅‫ؖ‬屳岥展‫ݺ‬৚๑岒岈৏৒屵‫و‬ఈ屖岅૮౲屳岥ড়ߴ岈‫ݡ‬௜山屦‫ݗ‬౾屯岦岀属岥屆ड़ఱʁྫ࿪ ೧ౕ %岅‫ؖ‬屳岥ࢊ‫ָׯ‬࿊‫ܠ‬峢岶屎島峭ҫ‫ؽ‬࿊ࣁྋड़ఱʁ୊ յ‫و‬੏րַਬ਒ճ٠ࣁྋ

ྡজ‫ݳ‬৖岒岈૥‫غ‬಍೘居ਏྏๅृ岈؏఼履岣ড়݇෉屧૥‫غ‬ট೟੏ౕ岄岃岈఑‫ݶ‬屦岄屯岦岀属屹屆˲ %岈್ஊ֌ট೟੏ౕ峷峝島崀峆௪எ居৿屹岄ฯ‫ݧ‬ঊؒ岈੏ౕઅ‫ܯ‬岬ಁ岘屢屹‫ٶݶ‬屦൅ड़屯岦屹屆ਕ岬ଲে岂屳岥ਫ਼ໍՌָ屇ҫָ‫ڂݜܧ‬岅‫ؖ‬屳岥ྛཀྵࢨਓ岈Ҳ෨岬րਜ਼屳岥݇ 

ड़ఱʁྫ࿪ ೧ౕ %岅‫ؖ‬屳岥ࢊ‫ָׯ‬࿊‫ܠ‬峢岶屎島峭%ࣁྋ䑷        䑷  － 91 －

        ஊ֌ট೟੏ౕ岂峔屎峌岈‫༽׈‬岒岈‫غ‬ଶ)6)-01.)/4

୊ஊ֌
ট೟



%4%0--)'4,/*

୊ ஊ֌
ট೟

  ஊ֌ট೟੏ౕ岈‫༽׈‬Ն೵੓岂峔屎峌ཤ‫༽׈‬ʁࣆྭ屮岂岅/( %5/'+峊峷峲屎峄峴崀岈峌屎岿峐峕屙૟ఈ屯岦岥ଲে੣඾岈ಝ੓屚‫ं׳‬ʶ݊৙ंᶅ ௗ‫غ‬屇୉ྖ岈ྡজ৏岈ࣰ੹履岣居屜岣屹岄Ճ஍屦඲Ճ屯岦居ҫྏ岅߶属߫‫ݛ‬屦‫ࠒݡ‬岘岦岥඾໪ᶆ ָस岈ட੷岅岢岥屜岣屹岄Ճ஍屦‫ݡ‬属屺屯岦岥඾໪屙੏ౕ岅ଲ屳岥‫غ‬ଶ屚 ֋൅履岣ࣆ‫ۂ‬岅層屫岥༩‫ݡ‬Ն೵੓岈޴৏

ㄥ
ㅒ
ἁ
Ỗ
ㄟ
ἂ
ㅛ
ジ
‫׈‬
༽
ッ
ヺ
ヹ
ㄽ
ỽ
Ỗ
ㄢ

屙࿨఼屚

9 ૥岛岅৏ࢤ岬屯屵居Ձ౵履岈峫峚峌岱峇岈ಕ岬ࡠ岥
9 ̏ஊ֌ট೟࣎岅岉居శ෉ࣁྋ履岣ਬఈՆ೵岄༙ް੓岅‫ؖ‬山岀ඬ岖屠屳岥屆 ྡজ৏岈඲Ճ岉居࣑‫ݩ‬岁岉岄屩居ࣰྡজ岅層屫岥峔屎峌岅岢岥඲Ճ岬Ն೵岅̏ஊ֌໪ট೟岅層屫岥৻ࠬ৏岈峪岱崀峕岈໎֮Կ ༙ް੓岈ਬఈ岅‫ؖ‬山居岃岈岢屠岄඲Ճ༽ࣁྋ岬૟ఈ屳岥岈履屆ච屴山岜‫ৄݗ‬దྡজࢾ‫ݩ‬岁岉岄屩居୵ࡩదࢾ‫ݩ‬居岜山屩岉ඉྡজ岄岃岜Ն೵岂屳岥屆 ̐ஊ֌໪ট೟岅層屫岥峔屎峌फॄ๏๑岈Ն೵੓岈‫ݗ‬౾9ট೟ࡃ岙඾岬৏ࢤ屯屵岀居फॄ山屹#岬༽属岀
ਅ੧岬屳岥屭岂岁居岢岤ྡজద岄қٝ屦ൕӫ岁屧岥
9ௗ‫غ‬屇୉ྖ岅峔屎峌फॄ屦૟ఈ屯岦岥岜岈岉居Ӻָదघ๑岁居ඇ༽岬ཊ屢屹඲Ճ岜岁屧岥岈岁岉岄属履9Ҳൢ޴߁ࠄ屦Ն೵岅岄岥屭岂岁࢘༽屯岦岞屳屩岄岥 ௪৙岈ྡজࢾ‫ݩ‬居ྡজ‫ڂݜ‬Ґ֐岈๏๑岁岜居࢘༽屯岦屹峔屎峌岬ட੷山岀඲Ճ屳岥屭岂岬Ն೵岂屳岥屆ྭ屢岊居؏ࡱ‫ڂݜ‬居峹峈峤峕岞岸峸峓৚ๅ岄岃岬༽属岀Ӻָ௒ࠬద岄घ๑岬岜屻属岀層屭岄屠৖߻岄岃屦૟ఈ屯岦岥屆

ஊ֌ট೟‫ޛ‬岅居峹峈峤峕岅඾໪‫༙ݽ‬岈岬屾屫岥屭岂岅岢屽岀居峹峈峤峕৚ๅ岬峦屎峆岅山屹岬༽属岀居Ձ౵履岈඲Ճ屦岁屧岥࿰ૌ岙‫ݗ‬౾屦岁屧岄属履ʃ䑷     

༩๹

‫ࠬݗ‬
ਏஇ

݊߃ଁ਒

ᶅ

‫ۂ‬ແ৏岈
峷峆岼؇ཀྵ

ਏஇ岒岈
岯岼峈峆岈
؈ҝԿ

࣑ྏ

༩‫ޛ‬

ᶇ

‫ؔं׳‬岈
৚ๅ‫༙ڠ‬

බয়ң࣍岈
ࢩԋ

໪

   

ট೟岅චགྷ岄峔屎峌岈岱峮屎峅‫ݗ‬౾՟ୌ

ୖᕷᚋ䛾ಖ㝤ྍ⬟ᛶ屇ड़ྙ屯岦岥峞島峮屎峌屦඲Ճ岅༙༽岂ࣖ山屹ช‫ݛ‬౵屇‫ޛ‬岧޴屧峔屎峌岈մੵ౵屇৿‫و‬੓岈߶属峞島峮屎峌岁屜岦岊居ช‫ݛ‬岜岄属屆ฯ‫֐ݧ‬ญ༽ྏ཈ඇ

ࠐ઄峷峆岼岬൓ఈ屳岥岜岈屆
ʤ$$Ґ৏岉߶峷峆岼居岂属屠൓ఈ岬ߨ
属居චགྷ岄࣑ྏ岬֋࢟屯屵岥岜岈ʥࠐ઄峷峆岼峞島峮屎峌岂ࣰࡏ岈ࠐ઄‫ं׳‬岈‫ؖ‬࿊岬ࣖ山屹峔屎峌༩๹దް೵ްՎ岈඲Ճ岅岉ඉ৙岅࣎ؔ岬གྷ屳岥屆峎峰峹崀峅ਅ੧

୊̏ஊ֌ট೟

ˠ峟峕岈峔屎峌岁屜岥ఖౕ֮೟岁屧岥৖߻岉Հ఼਼෉屫岬ߡ屢岀岜岢属岈岁岉岄属履ʥ୊ஊ֌ট೟

༩‫ࡱ؏ޛ‬岈ްིԿ

༂ࣆট೟岬岂岤居ฯ‫ݧ‬फࡎ屯岦岥Ն೵੓岈߶属岜岈 ੼࣊ ۢ෾फࡎࡃ岙岈඾      

੣඾岈展࢘༽໪ద‫ٶ‬岍ްՎ屖岈岱峮屎峅ট೟岅චགྷ岄峔屎峌岈岱峮屎峅‫ݗ‬౾՟ୌ

৏ࢤ‫ޛ‬岈ฯ‫ݧ‬Ն೵੓屇௪৙岈݊߃岯峤峷岂岕 屇઎਒ҫྏ岖ಋ屲屆ҫՊ޴屫岉‫ ݜ‬屇મఈྏ཈
‫ڂ‬岅ࣁ屳岥屹岛岈ট೟岂
属屠Ғ஖屿屫岉Ն೵履ʃຌ峤峺岽島峭岉ਫ਼‫׈‬स‫׵‬බ岞屠屾බ岈峷峆岼Ҿࢢ岂山岀೟ࣟ屯岦岀属岥ਯເ্֒岈૥‫غ‬൅‫ݡ‬岬ߨ屠屭岂岬໪ద岂山岀属岘屳屆屇ຌ‫ؽ‬೵屦௧Յ屯岦屹峆峫屎峕岳岶峐峎岬屇屭岈岢屠岄#岁岈ਅ࢘༽山岀属岥ਕʕʕʕ໌岬ଲে岅居ਯ੧岉Ն೵履ʃ
ເ্֒岈༙ໃ居ಊ޴岅屾属岀௒ࠬ山居ਯເ岈࣯屦屜屹屢岥݊߃岒岈Ӫ‫ڻ‬岅‫ؖ‬屳岥‫ڂݜ‬岬ࣰࢬ
屇‫ݺ‬ਕ৚ๅҐ֐岈峆峫屎峕岳岶峐峎岅फॄ݊߃岯峤峷ద岄඾໪岁屜屽岀岜居ਏஇ岅݃岍屾屩Ն೵੓岬ࣖࠨ屳岥屯岦岥৚ๅ履岣෾ੵ䑷  峎峰峹崀峅ਅ੧岅岢屽岀居ಝࡒ຤岉घٗྋ       屙ࣆྭ屚 ҫྏ‫ؖؽ‬岅層屫岥༙༽੓岬௧Յ඲Ճ䐢 !%2*)4ҫྏ‫ؖؽ‬‫༽׈‬໪దʁ ਏஇࢩԋ峷峝島崀峆௪எᶅ岈Ԣ༽ʁྡজ峔屎峌屦ঙ਼岈৖߻੣඾֕གྷʁ ෵਼岈‫ࠬݗ‬峔屎峌岬‫ݫ‬岅居ಢࣙ岈岯峸峁峷峇峭岁ਏஇ岈ޫึ౵岈৚ๅ岬఑‫ڛ‬屳岥屭岂岁居ҫྏॊࣆं岅ଲ屳岥ਏஇ岬ࢩԋ屳岥੣඾֕གྷʁ ຌସ੓߶݄ѻ঳岬ଲে岂山屹࣑ྏ岬ึঁ屳岥岯峤峷୊ஊ֌ট೟

峺峩峐峕घढ़

ղ‫ࢩޤ‬ԋ

ࣁྋ岁岜屽岀居୊Ҳஊ֌岈ট೟屦Ն೵履ʃ

䐡 !%2*)4‫ं׳‬屇݊৙ं‫༽׈‬໪దʁ ࣑ྏ੣඾岈展࢘༽໪ద‫ٶ‬岍ްՎ屖岈岱峮屎
峅

୉ௐ屦岭

೶ಊຼᚇ
‫ڵ‬෨ત居഑घढ़ࢩԋ๎ࣻત࣑ྏ‫ܯ‬ժࢩԋຌ峤峺岽島峭岁岉ਯເ岈࣯岬ਬఈ山岘屳屆 屇ਯເ岈࣯岬඲Ճ屳岥ࢨඬ岂屷岈଎ఈ੠ೖ৙岈݊߃ң࣍岈໪ద岂山岀屮࢘༽屩 ౕ岅‫ؖ‬屳岥ࣁྋ屺屯属屆屇඲Ճࢨඬ岂ਯເ্֒岈‫ܐؖ‬੓岬ࣖࠨຌ峤峺岽島峭岉গཔద岅岉ਫ਼‫׈‬स‫׵‬බ 屳岥ࣁྋʤช‫ݛ‬居)%3,&,-,47345(7岈岞屠屾බ岈峷峆岼Ҿࢢ岂山岀೟ࣟ屯岦岀 ݃Վ岄岃ʥ
属岥ਯເ্֒岈૥‫غ‬൅‫ݡ‬岅ༀཱི岀岥屭岂岬૟ఈ山岀属岘屳屦‫఼࣎ݳ‬岁岉ॉ෾岄岵峠峔崀峆岉屜岤岘屵岭屆    屙ࣆྭ屚 ‫ع‬ଚ岈ྡজ峔屎峌岬ཤ༽୊̏ஊ֌ট೟

࠸൅๹ࢯ䑷  

展༩๹屖ްՎ岬඲Ճ屳岥岈岉居ௗ‫غ‬履屾୉ྖ峔屎峌屦චགྷ岅岄岥屹岛居್ஊ֌ট೟੏ౕ屦屜岦岊居֋൅岈Ն೵੓屦岁岀屩岥屆

ࣆྭᶅʁ

ҫࢥ岈
ҫࢥ
ਏஇࢩԋ

੣඾֕གྷʁ ຌ峤峺岽島峭岉峆峫屎峕岳岶峐峎岁‫ݗ‬எ屯岦岥ରಊ岞ຼധ岅‫ؖ‬屳岥峔屎峌岬‫ݫ‬岅ਯເ岈࣯岬ਬఈ屳岥峤峺岽島峭岁屳屆ࠐ઄峷峆岼岬༩଎屳岥峞島峮屎峌岈ड़ྙ   (%'"*+($%䐠 !%2*)4‫ं׳‬屇݊৙ं‫༽׈‬໪దʁ ਏஇ䑷  

ҫࢥؔ岈
ҫࢥؔ
৚ๅ‫༙ڠ‬

ᶈᶉ࣑ྏ‫ܯ‬ժ
ࡨఈࢩԋ༂岒岈岯岼峈峆岈؈ҝԿ

䐟 !%2*)4‫ं׳‬屇݊৙ं‫༽׈‬໪దʁ ༩๹୊ஊ֌ট೟

ҫྏ‫ؖؽ‬
ҫྏ‫಼ؖؽ‬৚ๅ‫༙ڠ‬
屇մੵ

,*" ))

峔峅峌峸࣑ྏ

ʤ峔峺岱峕峕屎峫峑ࣁྋ岬Ҳ෨րรʥ ຎྭʁ੣඾֕གྷʁ ‫ं׳‬岈ਐௗ岞ର॑居ਫ਼‫׈‬स‫׵‬居ժ଀ॶ‫ݡ‬౵履岣ࠐ઄峷峆岼岈ࢨඬ岂岄岥峞島峮屎峌岬ड़ྙ屳岥峤峺岽島峭"*+#&(- 屙ࣆྭ屚 ྡজదқٝ屦າཱི֮岈ࣆྭ੣඾岈展࢘༽໪ద‫ٶ‬岍ްՎ屖岈岱峮屎峅ҫྏ‫ؖؽ‬
࣮‫׳‬峷峆岼༩଎ᶆ 屙ࣆྭ屚 ༩๹ްՎ屦າཱི֮岄৖߻୊̏ஊ֌ট೟

ট೟岅චགྷ岄峔屎峌岈岱峮屎峅‫ݗ‬౾՟ୌ

৏ࢤ‫ޛ‬岈ฯ‫ݧ‬岈Ն೵੓ຌ඾岉居ຌସ੓߶݄ѻ࣑ྏ岬ࣰࢬ山 屇ঙ਼঳ྭ岅層屫岥峢岰屎峅峠峷峓岰ࢾ‫ݩ‬岈 岃岈屪岣属岈঳ྭ਼屦屜 屇઎਒ҫྏ岀属岥੔ਕ岬ଲে岅༽属岥屭岂岁居࣑ྏ ݃Վ岦岊居ްՎ屦ਬ଎岁屧岥 屇ۢ෾ʃްՎ屦߶岘岥Ն೵੓屦屜岥岂ਬ଎屯岦 屇ඉྡজ岅層屫岥੓೵֮೟岂Ն೵履屆岥峤峺岽島峭ҫྏ‫حؽ‬岁屜岥屆ˠ峷峆岼岜屷岦岕岃߶屩岄屩居ࣰࡏ岅ࢤ৖岅層属岀屷岈ްՎ岬֮೟山岀属屧屹属屆ຌ඾岉居੔ਕ岈ຌସ੓߶݄ѻ঳岈࣑ 屇ࣰࡏ岈‫ं׳‬岬ଲে岂山屹ࢤ൤‫ޛ‬௒ࠬ屇ྏึঁ岅༽属岥峤峺岽島峭ҫྏ‫حؽ‬岁 ࢾ‫ݩ‬峔屎峌ʤ‫ع‬ଚ࣑ྏ岂岈ർֳʥ屜岥屆ট೟‫ޛ‬岅ྡজ峔屎峌岬
༽属岀峎峰峹崀峅ਅ੧岬ࣰࢬ୊̏ஊ֌ট೟

୊ஊ֌ট೟

੣඾岈展࢘༽໪ద‫ٶ‬岍ްՎ屖岈岱峮屎峅ট೟岅චགྷ岄峔屎峌岈岱峮屎峅෵਼岈‫ࠬݗ‬峔屎峌岬‫ݫ‬岅ҫྏॊࣆं岅居 峹峕峺峔屎峌岅岢岥੓೵ࢾ‫ݩ‬ਏஇ岈ޫึ岈৚ๅ岬఑‫ڛ‬屳岥屆ҫྏॊࣆं岅岢岥࠹ॵ岈峆岼峷屎峘崀岽岅࢘༽屳岥屭岂岬૟ఈ山岀属岥屦居༽属
岥岯峸峁峷峇峭岈‫ৄݗ‬屦ཱི֮屯岦岀層岣屴居࠹शద岅岉ҫࢥ屦൓இ屳岥屭岂屆෵਼岈‫ࠬݗ‬峔屎峌岬‫ݫ‬岅ҫྏॊࣆं岅 ᶅҫྏॊࣆं岈൓இ屦 %履岣岈৚ๅ 屇ଲ山岀居ਏஇ岈ޫึ౵岈৚ๅ岬఑‫ڛ‬山居 岂ಋ屲岁屜屽屹岈履岬֮೟屇ॄ੷山岀඲Ճ屆ᶆྡজద༙༽੓ࢾ‫ݩ‬ҫྏॊࣆं岈൓இ岬ࢩԋ屳岥屆ʤҫྏ‫ؖؽ‬岅層屫岥಍೘઴屇಍೘‫ޛ‬岈‫ݡ‬ཚ岂山岈รԿ岈ർֳ‫ৄݗ‬ʥˠචགྷ岅Ԣ屲居岈ࠫ෾ָस岬‫؜‬岛居ࠫ෾岬岯峸峁峷峇峭岅ൕӫ屳岥屆‫ݗ‬౾՟ୌ
屜岣屹岄Ճ஍屦‫ݡ‬ड़屯岦屹৖߻峎峰峹崀峅ਅ੧岅岢屽岀居屜岣屹岄Յࢋ

Ҳఈ岈ྡজ峔屎峌ʤ࣑‫ݩ‬Ґ֐岈峔屎峌ʥ岬ཤ༽山岀居̏ஊ֌໪岈ট೟屦屯岦岥屭岂岁居ਟଐ岅৏ࢤ屦岁屧居࣏岈峔屎峌फॄ屦山岞屳属屩岄岥屭岂岬‫غ‬ଶ屆࣑‫ݩ‬岬山岄属峮峷峐峕屜岤屆ҫྏ৏岈༙༽੓岬඲Ճ屳岥઴岅居展Ձ屦岁屧岥屖岬໎֮岅山岀̏ஊ֌໪ট೟岬岂岥屭岂岁居৏ࢤ山岀居৏ࢤ‫ޛ‬岅༙༽੓岬඲Ճ屳岥屆䑷  䑷        

－ 92 －

   ৏ࢤ‫ޛ‬岈ฯ‫ݧ‬岈Ն೵੓    屙ࣆྭ屚 ҫྏ‫ؖؽ‬岅層屫岥༙༽੓岬௧Յ඲Ճ䐣 !%2*)4ҫྏ‫ؖؽ‬‫༽׈‬໪దʁ ਏஇࢩԋ岅ଲ屳岥ҫྏ峔屎峌ཤ‫༽׈‬岅層屫岥‫ۂ‬ֆଈ岈‫غ‬ଶ岂՟ୌ•੣඾֕གྷʁ ๎ࣻતժ଀!ժ଀岂履ժ଀居峹崀峕岿崀 岄岃岈)බร‫ݗ‬ड़岁居岬࢘屠岢屠岄岜岈屆୊̏ஊ֌ট೟

୊ஊ֌ট೟

੣඾岈展࢘༽໪ద‫ٶ‬岍ްՎ屖岈岱峮屎峅岘岂岛ট೟岅චགྷ岄峔屎峌岈岱峮屎峅ժ଀৏岁ʕʕ岈බร屦ଚࡑ屳岥ޫึ ୱର੓೵ࢾ‫ݩ‬ʤ‫ౕ״‬居ಝҡౕ居ْӆҒ஖岬峀崀峡峲屎峌屦ࣙಊ‫ݗ‬ड़山居峫屎岺 ੓居ْཇ੓ʥ崀岽屳岥峊峢峕岳岵岯屆ҫࢥ岈ಣӪ࣎岅ญ༽屳岥屭岂岅岢岤බร岈‫ݡ‬ཚ岂山‫ݰ‬ঙ屦‫ࠒݡ‬岘岦岥屦居‫఼࣎ݳ‬岁岉ཱི֮屯岦岀属岄属屆

ժ଀৏岁ʕʕ岈බร屦ଚࡑ屳岥ޫึ ྡজద༙ް੓ࢾ‫ݩ‬ʤҫྏ‫ؖؽ‬岅層屫Ғ஖岬峀崀峡峲屎峌屦ࣙಊ‫ݗ‬ड़山居峫屎岺 岥)಍೘઴屇಍೘‫ޛ‬岈‫ݡ‬ཚ岂山岈ร崀岽屳岥峊峢峕岳岵岯屆ҫࢥ岈ಣӪ࣎岅 Կ岈ർֳ‫ৄݗ‬ʥญ༽屳岥屭岂岅岢岤බร岈‫ݡ‬ཚ岂山岬‫ݰ‬ঙ屯屵岥屆‫ݗ‬౾՟ୌ
   ࠕ‫ޛ‬居 ஊ֌ট೟੏ౕ 峷峝島崀峆௪எ 岬‫༽׈‬山屹岈ࣰ༽Կ屦਒岛岣岦岥屆
#౵岈‫༽׈‬岈層属岀居‫ݺ‬৚๑屇ྛཀྵࢨਓ৏岈੖ཀྵ岅Յ屢岀居岃岈岢屠岅峔屎峌岬ட੷山岀属屫岊岢属履 峔屎峌峦屎峆岈ߑ஛居༂‫ؽ‬๑岂岈੖߻屇௒੖౵屦චགྷ岅岄屽岀屩岥屆屜岣屹岄Ճ஍屦‫ݡ‬ड़屯岦屹৖߻峎峰峹崀峅ਅ੧岅岢屽岀居屜岣屹岄Յࢋ

౲֚ࣆྭ岁岉居ஊ֌ট೟੏ౕ岬༽属岄屩岀ট೟屦屯岦岀属岥屦居ᶅ୊Ҳஊ֌ট೟岁੣඾岈岜屾੓೵岬ඬᒙ山居ᶆ৏ࢤ‫ޛ‬岅ҫྏ‫ؖؽ‬岅層屫岥ྡজద岄༙༽੓岈඲Ճ岬山居峔屎峌फॄ岂඲Ճ屦ࣰࢬ山岞屳屩岄岥屭岂岬‫غ‬ଶ屳岥䑷  Հ໌Յ޽৚ๅ岈‫༽׈‬岄岃岬‫؜‬岚‫ݺ‬৚๑屇ྛཀྵࢨਓ岈րఙ岅岢岤居‫ࣰݳ‬ద岄峆岺屎峭屦‫ݡ‬屢岀屧岀属岥屆ࠕ‫ޛ‬居ҫྏ‫ؖؽ‬屇‫ؖؽڂݜ‬岁岈ࣰແద岄岹岱峖島岱崀岈੖ཀྵ岅岢屽岀居ཤ‫༽׈‬屦峆峭屎峇岅ӣ༽屯岦岥屭岂岬‫غ‬ଶ山岀属岥屆৏ࢤ‫ޛ‬岈ฯ‫ݧ‬岈Ն೵੓•屇屭岈岢屠岄峔屎峌岁岈ਅ੧岉Ն೵履ʃ

ٗढ़岬‫༽׈‬屳岥岈֋൅岅層属岀գ‫ڊ‬岅ட੷屯岦屹୉ྖ岈ҫྏ৚ๅ岬Ӯକద岅‫༽׈‬屳岥චགྷ屦屜岥屆

ࢊ‫ָׯ‬岁࿊‫ܠ‬山居ҫྏ峔屎峌岬༙ް岅ཤ‫༽׈‬山屹岈֋൅屇ऀճࣰૹ岬ਬ਒山岀属屧屹属屆   䑷  － 93 －

      

! N  '"6NXZ]a

7@EH>S   
!"


'"6MBS^e[N80'oseqpuv-fnmctqp 

MGIMDQ@LO
36@ADK

-@ADK

Yyg
¦^
Ó¼ÉÂ¾²¿µ3s 8
P Z´ÒÀ®ÑÄ°ygk¥5nÓ¼ÉÂ§x¹»ÀÌVÖ ¡Z

ÑÃÅÑzygÑÃÅÑjÑÃÅÑ 
,J¢¨Eyg
U©fvygOGÖ&4ygU©>0yg@ADK

XTyg
?yb
)`XT
R%B
XTS
X]yg("CA

0*36@ADKyg
XT
2yg
]yg


!

£zyg£XTyg,J¢hgXTzyg
hgXTyg,J¢&736@ADK,5@ADK

@ADK

1Rzyg
1Ryg,J¢'36@ADK"(%#$%'<QCMO?@ADK#/@ADK

kWu
¨
X XT
}XT

I
`/
ÓºÍÕ
D/
9Öª
k!
ÙtÚ
>0yg
Ù>0G«MÖU©>0Ú
lz
ÜÞÛ
hgXT
£XT
kgXT
ÑÃÅÑÀ×¹ÏÕ1RÙ\tÚ

ygKygpj 8
p¢
pz
p<
pH
p»¶ºÎ×Ò 8
p>r

"$
@ADK
z
>0L
lFL
z¢ 8

MA>$

@ADK

6
i
6Ölcq

>MF=NHA@ADK=ND.1(6'N7(
6:Ç³×´»Ø´ÒÀ´ÒÀdÖX|lÓÊ×Â 8ÀÕÉÓ×Â
l»¶¿¾{FLm¢)Ç­°Òm¢6@rQ
i¤¬ B
6ÉÔÇ­°Ò)Pz6
)P 6
kW6
kWË¿É
6X|
kWyg
>rZ
7(d
Z
¾×ÌlCAÖ´±Õ½×¸°Õ
tXT

%@ADK?NQJ:;9
@ADK
§+@rQ
Ð°ÈÐÑ
¥Í×Ò
§+»¶ºÎ×Òyg

7@EH>S1'*"36
@ADK

EQB:;9G:A@ADK

#/@ADKl7(;m¢*[R
Á×½;R

   

lOGeaygeaygp$7(ygp$yg

D/XTygÇ¯ÒÌ®ÑÄ°d/¢yg
ßÝ&4yg
D/_lygÓÊ×Â 8)36@ADK#7(yg#o¾²¿µM>0CA=yg

+P8436@ADK9yg9»¶ºÎ×Òyg
ª yg
9¢Öª ¢

@ADK$¹»ÀÌiyg¹»ÀÌZ%yg¹»ÀÌË»½yg·ÕÆÎ×½±¯Ò».w¸×ÄygµÐ°®ÕÂyg@T-]OC(8+V@T   " 1&-]
#4KA[IQD'F:=,-] WB-]
DG@TP/@T
U7E'F
>)*'F
N5.'F
U7E! >)*! N5.! RZ! 
DZ23
;?0




@T9\
S6CH 'FL'



%
%
%



'34PN^e[ :,-*)IN^e[ SU¥¬¢®ª| 1

,%





(

/

#!

 

*-



#+

 

0.



!+



!+




~®w­­­xz{@)`rY
u(u>u<³ u(u>u<9ttm¡®

$
/
&

'

*-

 

)"&



}}a®©¢5`rY
u(u>u<³ u(u>u<9ttm¡®－ 94 －

MX$











2@ADKJ¤B~6Z    


P/K

%
%

J<


%

%
%
%

  5(*)N^e[CE )o

E*/²BACdjz²HQ4¡®5
=?3^¡®²pª z
7$WN²¯o N §°z bkN²hl §y DT¤£¨¦W6+²hl §y |£§/²hl §y(  
0/Jdrk/?

%

 "

CE
ghkp
!#2
1 $2)54.
D:@>7AB68>
B $235E

>0
Jdrk
4#

23
& !(
#$%'






"
*

 23'FZ
3'FZ
lti"
"



=C<
'-

  * )+ 

5+ '`\_deWf   gV#>FcYZ_b,N 
JdrkS` ;ltib
UNMLKghkp\@A
VaO*!(Y^\P:QTA 9

- $ +'4/0  ,8@9:AB?&2'1"#2032
12(>;?!1% ) <56=B7B2*.

q'R|!:z% 
KFX0OBeea";-s« ¬®ª^P¯°.Y#«¢©SU

H]ltibNB
IG=UXN<[ltib UN
MLK\1DSUOoq' R ±Oo!:¯_²q'  h ,J­[\­Z T
iM82°q' hn&Oo

Jdrk
Jdrk
23
ghkp                 

  " $   

$   $   


.YVgdj¯ª °/Lzv]Gcf Ii X 

Hhijm\_a,&6" $   

Y
 




87$b.RW$)




 


 23
'F

%
;?>896B+=C<$&,'=C<  


(8
 


 
     

! #!
 

－ 95 －

AN^e[O&7N '34V.$EH
DTS@;34?R+DTSQ=S<
3N%O  @9E>CJ@=S<
%N^e[ I  @XZ]a DTH>SO0RTL?GF<
cYZ_b,-LKIO;+)L^e[2@/U
TH>S@=S< － 96 －

  









8>,




 2() 7.9     -* %#%"

   $

   .

 

－ 97 －

+!

+

+'&()/,－ 98 －

      -* %#%"

   $

   .

 

－ 99 －

+!

+

+'&()/,－ 100 －

  



!


Üw'*¿[,Î("-"HÑU(" w'*¿,""Î("¢ ¦Á 

ÝxÙ}gc¸Þ ¥£,¦Á " ØÈÚ¤°£,³ " $* Ô­Õ+)J9G6a ©TÖÏ© o '*)Py 'b{$X* 'qe  ¨tu ~) %d_sq¶ ¦Á)\v rn» dºf¬ÕÅ B.B8/ ( «©
$* Ä¬oÒËÉ$s`  *,2F=D 4A1;§p ©)#R,! ß,¡#ËÉ)¾ )·" % MÌ¹
53@B8/¯9G6a ©´IÃ[Q,V±5><G )º·" ¸kh-mÚ Á ZÔ­ª%Kªg·)\v r

 jÙmÚÊNl²)    $* ÕS¸z ÈÚ,ÆÊ$'  #ÀPr  oL   B.Cgc ¥£ÈÚÁ#¾ËÉ ¦Á 
 OÔ­Ñ_,?0F¼) [Q®mÚ¢ÈÚ,)   # TÖ·%W NÂl]ÆÊ¦   $* Ô­ Í,ËÉ)×^iªTÖYÐ*) Ó¾¾µ;07 / &=E:60=Û½¥Ç| )$*"-ÞYdX@Â9,)   )b{~ËÉJÉ"¤¯|³*$" N -ED~
 ·_f¬PÔ­£¨)m)¦{­$'$* PNÍ"l _  ¨tu**¥£-j´,²)    $* )Ä¬oÒb{·¥¢Â\v,¤Æ $* ©
'*) oh($Â\v ¤Æ － 101 －

 Ä¬oÒ)ÈÚ ¤' ¥U$* ½OÄ¬oÒÕ+)Å,¼)# ¥U$* Ô­h(¯-)#
 $* Ô­%WM oJ×Õ)¥UËÉ£**ªX'
3   $©
 iÓJÐZ>@G)F $* K+À A^  [Q®dl ¦Á )=EA(#
Ý',+ ¶Æ¸Þ /dl,µ

   HÑ¶Æ  ßTÖb{qÎ%¥U¾*ËÉ£ ¦Á
#


 g}Zl¥£ÈÚNËÉlF#4:¦Á $* CKe=E4:g(N&¯%t±,°¥P 9; |8 )¥¢Â£, " ¼~ % ! Å 3 ~hD@*,sÖuÆb{ËÉ o.=9G:   $* S)Ä¬oÒËÉÍz,VÕ¿)   
 =EA(f¬P5³ ÈÚ  '¤(" $* Ä¬oÒ¥£ÈÚ  # $* ³*)TÖÄ¬IÈÚNl¦Á)
"





 K7 r 0?G%
 ¥U $* »Kt± ,.Z(TÖÏ©6$¼ )# £¨Ô­q'
 $* b{·%¥£ + ¥£ÈÚ%mÚ¢,¦Á)#q""·É$o,¦¦Á,¡ °s qe £¾ o y w)mÚ¢$ -Á* ""(Ç* Ò)T\®
Ì~mÚ )#EG"CO%(®Joª,ª)  Ó¾)£q+( Õ..J$N
?Z{ º  s¬¾b}Ù,¼ * º

－ 102 －

 q+) ,xM±Èq" [Q> ¿*_
 $* ,h(c ÈÚX¥£¾,²)    ¥£mÚ¢,A^ ²)  r' Ä¬oÒ9G6a ©$¥£É¢ ¤
 WM oh(Õ)¿Á µ  g·(" $y©Ê-ËÉ  dl ¦Á  j8G4%CGÕoÜWËÉÍzÈÚ ¦Á 
 OÔ­£»Kb{}Z Í#'*)¥£sq¦Á,¡#)  # <¦yÑ% $* b{}ÙH«,²* jªX'¿)¥£ÈÚ¼~=Í¼)Â£B.C60(o,²)    ¥£ÈÚNaËÉ,¶Æ # WM ocb1LGL o¡ËÉ
 $* x)Ô­[©eØ,qg·

*)+( JÐZ# CÂËÍ¼ $º
 f¬9G6a ©:Í,¼)Ol`·,²) #"f¬9G6a ©¸¥£!G;C$}#¤Æ #^ ¾b=·,°{3¢ ²\v$O=w\v,3
 $* Õ)ÈÚj_Ð'rÁ®¿¢¿Æ)  ^# ¼~*?GG,='¿,µL+*)X,¤   1Lcbf¬ o o '* ¥UmÚ¢¢y! l & +
 WM oÉ¢ _(% ¦(% "#Û&q"－ 103 －

 "Í$ÄË×_ NQ$GA(B#$*,²(" $* Ô­)¾b%mÚ¢,ÆÊ  jªX'dl%ÈÚ|ËÃÌÛ# $* TÖÏ©9G6a©Õ)ÈÚ¥£Â£

º

¦Á

"

 Nl y¿ " $*  ITÖJÎ,Í#   IÈÚxpd,²)

 ¨tu**ªX£ º ¦Á  Ä¬oÒ\vØf¸N¡\v
 9G6a ©Õ)· ¦ " =EA(f¬P,(^%TÖ=E5¸N #"WM o$n H )H· .=E
G,Â)¾ )ÆÊ" H¹É _Ô®\v 'Å µ 

8G'xrÁ®Æe

 $* x)v¼*Ä¬oÒ·%l,²)






¶

 $* :DF;ÈÚ _
 jRQ·,²*Nb{l,.)¶
 ¼~%¨d "

 rÁ®¿¢'[Q,²´q*"²\v r# ªXÅ µ& ¥£ÈÚl y¦Á^ $* Nf¬smÚ,IrZ" ËÉ)Xs" &P,'6 ¾ )#y

  $* ¥£ÛX´Þ ¦Á    $* ÈÚÕjZ'­½

  ÈÚ -)¦Á^"  $* £¨Ô­f¬9G6a © Ó¾)O=
9G6,@t)  ØfSØs)Ak£¨,¼f¬ÕÏ

－ 104 －

Z%9G6,Kh)O&BGf¬9G6a ©l%
[×¼)K7,¦Á Ø$g·  µ f¬¥Xf¬ oh(%OAka©¥£,µ )   sqFk(" $* Ô­9G6a
"

©CGC]{Õ+),'#ÆÊ ½»OªXN  $* TÖYÐ "§®#dXdlÀ¢Øfg·("H
9G6a ©$* 0Y$Ý42
"#sqg·("
 $GA(&(!¬)ÕJ[&ÂÉ ¼+* $* ÈÚNl´ y¦Á " [1IÔ¥XG,d¶)   #  ¥£mÚ¢´  N½OÔ­om´ ©)
  9G6a ©¥X£¦Á ¡"  $* ÕSÔ­, 

0;A0FÒ)&s`Ä*(NÍ#sqg·("

  f¬PuÆ&TÖÏ©)Q®Å,µ  $* ,Ä¬oÒ¿¢'·)   ¶
 ¼~dlFG ¿f¬Õ£* ¿/5><G´
z!y¿@Å,µ  ""JÐ-sq+(%'BG " $* Õ)²Ê*"o]¤Æ

o%ÈÚ¦) W of¬Õ£¨)_ M %< Õ+(J#"+' 'JÂ9%9G6©b{ 'qÙJ)  ¦Á # ¬HÑ¬Ñ8G'$ÅÚ'§p)R{$µ¦Á,¡#)¾ )·)ÕÈ)sqK)
  $* Õ)$GA(  Ä=EA(Õ)ÅÚ$"&s%< ÅÚ $y  dl)¦{g· ÂJÑ_$r
0;A0FZ´s ")  "'O=Ô­$Í '  9/)F#G:jªX'r¿*Ô*ÈÚ µ¦Á ¡－ 105 －

"N$(Ô9/)F±   ·_·,¦)   f¬Ì~ ÆÁ)J$* TÖYÐ,)Ó¾ÈÚÆÊPX^*¼mÛ?F:Þ[ ksq"$* Hf(Â) Ï ($f¬IlÓ¾$R*,°)  Ó¾)}#s"  °Ø¾'©Ç´¦Á Â ) $("¾ sÈÚ¥£,¦Á "¾_¾_

 ÈÚ,¦¦Á) Yª b{®.=EG ÈÚÁ  ¦Á ¡"("
¼ Q­sqg·((®¿ÂÉ **
ªXÈÚ%t,S!'*)&l ¿ " ÈÚ ¦  $* TÖYÐs ÈÚ) N}A¼~*{Õ ¿NÑ,3   sqFk(""9G6a© $*  Nf¬­als ÈÚ) ^)f¬Õ5) 'J#)!  ¿¤
q"K7 * Ø©,³*)f¬Õ$ÂÑ)q+*" ) 'Í#q" f¬ oh(¦  W oTµ<¦yÑÕ= (*,h(¯ *) ,²)   &  $* Ä¬oÒb{e²¿,'* 1Lcb oGLcbo¦Á ¡"(NÍ#'*)l,²)   
 

=ÂÉ

   o g·



0;A0F,6)='Ô%¥£,µ  n+ÜW(\v®Øf¡h(*#  TÖf¬N$* ,Â9-ËÉ*&)  "_'"Â9 $$* %³*£,AÄ¦ÁIÍ  ³@*$* ,Ô­
O"No ' TÖYÐ.¿ËÉ g·
 ØËÉ rJÈÚ ¦*X­½¸
'?F:,* &
 Nl¥X¿¡ÈÚ²)    ¨ut**s) ,)¦{ÔÅ=Xµ$·'*)\v
$* +f¬84EGÕÈ

－ 106 －

I).08()

¸NoN[,cT,`×)  '¥P[Q¸)#ED*) <P It Ndl$>#£ * # AGi´PÍ¼Y$Ï`MÏ
 TÖÏ©%9G6h()Q® o,)     NÑ´U g  f¬9G6  a©Õ)¥£L,²)     jF¸Æ,Ä£{s,s)   $* ÈÚ +("·,}#¦ÆÊ #¼~=¨f¬Õ**À¢&* b{, M
f¬9G6,'0 © ))Q7$># PÛ#¦Á ¡"(" N$GA($K7o?Â&(¡EÛ)b{a©%Ä² 0Fa©:Í )·"& ×
"$* Õ)5><GÛg() Ûg,R$"TÖYÐËÉ Û"3_ ÞÍ-)K,² WM oÕ$1L
cb oK²'Fk
¥£%ÈÚ,jÙ'¿¢t   "$* TÖ9G6a©ÛWM oÕÅÞdl£ ¦Á "¬ÛÑËÉ*.¿mÚÈÚÆÊ ("£¨Ô­n+)¸T8(=Ã°{ÕÅ)Ñ_y
$½O^iª,· I¾)¾¢)¦{ #$* x)Ä¬oÒÕ^ TÆÁ)Ì~$§t(TÖYÐx·)½O,¢y!G;C )  _"~Y$ 9C-)K7$y_
$*  I,es)Øf¬¼~f¬Õ¨**ÈÚ,HÑq" ¦Á)   "·_¯®)f¬9G6a^#

©~Ilb{¯®)



¤Æ





¼~.9>.'[ %Â£,µ 
$* £ o '*$* ­a#ÈÚf¬9G6a©¥£¦Á,¡#)－ 107 －


N $* ½O$h(  .r*) [× 't,&_'S["¥U¼~%Ð£ +(sq.(""Q$Ô# q"Ä¬oÒÕ) ¿ 3
=EA(f¬Pxf¬¥XO¼~)Nf¬I¾AÄ
ÆÊ MU)  ¤Æ*$Zf¬P%f»OÈ'¥£b{%Ì~®Â9b{=+  ¤*q"=E
A(f¬[¹®¾N= )x·%}¬ÙÓ¾,·]7 R'Ø­Ó¢O¢Â'X,*'6·,g "|¥=EA(f¬P,Ô­J'Ä¬oÒËÉ sqg·("¥£ÈÚx)ÆÊ¨tu**ªX'¿,µk·É·$¦)   mÚ¢ +(% ¦Á '
$* ,h(c ¥UÈÚxptZ«h¯,¶Æ)  ­«N,[¦Á _$) ¼p­²y¦Á ) $( ÏZ,¼
9G6v;et%l¦Á ¡"$* x)f¬9G6a
(" ©ÈÚT¢y!

f¬l´g··¥ $* ,ti) X=h¯D®¦Á s )
$* h(¯-ÈÚ)TÖÏ©U(9G6a ©)ÈÚ¨ut**ªX'¿L  'fÅ7/% Ak,l Í#)£ VÕ¿'*º
¬HÑËÉ*Ke.¿¢As)  r j¥AÄÈÚ)s"¸-%f¬¸¸)B@G)F$
Y|8,±)+$|¥\$
96C2"O\ 4344 +D$¿° ! ¢(" 0G)Fª¹ %§pX*b{¯®:xs"$* )ÈÚ´ _
¥UÂ\v %WM oTµ%1Lcb oÁÊÃ $¶s"(  "Á²Û

!F;.1:,K,ÄÊ-A0;¦Á#Â

－ 108 －

f¬ oa©1Lcb oÏ`cb 0;A0F 6
*)­ o( Û¥Utk(£Í#)#Þ"Of¬ o|8·)­ + $&¢)
WM o·ÈÚ & _("·¥8(¨W8(Øf¬=EA( Q®s N $* &Â$¼+*)$*q¶Æ "$* $GA(!0DC\v&([Q,"Gq" N
Q $GA(&(8G'ÛÄ¬oÒ9G6a ©Þ,)Q®ËÉ ^Å¦Á %NQ8G'ÕÅ)Àdl,²)   [1 s"¼~%OÐªX'dl ¦Á sqØÉTÍ$ *,0F94ÜÞÝ³!)×g· )Ø[ "(¡

WM oÕ+)  4B.
$* dl,¦Á #¾TÖÏ©Å,>- $* Ô­,ÂJ#+ )stOFGO·È ¿'* "$E.'¼mf¬º[Q.,·96CCTÖ,* 
~Y$s)½O J ¿ ^»k*$TÖYÐÈ¡,|#)¦[¼®
 9CÏb¦ OÏ'*)¥£}#s'*dl,+(% ²# Æs4Ó¾\v Ø\v,Õ²#3_¦Á "-Q$²Õ,Ó )K

$* Ä¬oÒÈÚØf+(% pÛ
:4q+*)\v r #¥£ & ¦Á 
O='¿"b{X¾
Á ##')¢$* ÅÂ9Õ¢¦©Õf¬Õ¢¡¿$3 #Ä¬oÒª)#ÈÚ ' )=Ù'"#*ÂË* "f¬ o ©£f¬Õ\xp´² sqg·("}´Õ) o,)   － 109 －

$* TÖ¢qIÂ9dl +
Ä¬oÒb{Ä#=EA(f¬P_ÐÄ¬oÒb{ÈÚ +(% ²Fk
¨tu**S( ¦Á  N¨tu &5¼
$ ¼ ! ËÉ,~ y
WM oTµ+f¬D¥Udl¤Æ  '·ÍÇ¿N& f»Of¬P,2>TÖb{TÖb{,a®}'½r9)¿ )q+*¡¿ Õ Ï'*w* ¾ ÍÉT ('#¢,Ä   ¦Á ¡"(" $* Ä¬oÒQ C"Ñ_ rJqy out¥£h¯,3  *' $* Ô­,Â)Øf¶(" Nf¬PÔ­*TÖªYªq" $* ÕÅdl%¥Ub{£ÈÚs¿¢'²)
#





 $* Ä¬oÒÕ)¼~==8·,²)   ¶
ËÉÖ o,)     Ä¬oÒb{)ÈÚ ¤
Ñ%ÈÚÕ o '*#"Úr m¢ 4B.

ÅÚ 48 \v[×Í#'*)MÅ,µ "ÂÉP\v¡\v&N 0F$l´ ry # ¨ut**ªX¿Á µ# ¼~cluÅ,µ  Yª ¥£,   o F#4:|8*$+(% ¨tu **ªX¥£*ÈÚ*%Nlh(¯%¾,=DF¿L,¼ Øf9; )cr gc¸ oA )Øfµu'Pq¥£¦Á 
¼~=O=8¿,µ

  #¥£N.rg·－ 110 －

$* TÖ(Õ ÖuÆb{eÄ²}ZlÕoÙ 3 ªX


¿,µ

"

-

HkPËÉ*$º

 f¬PFG $* Â9-)  ¦Á  $* 0¤®¨W¥X6©fe% }Ù%¿Ã ´&)¸}¬%.}A" ¥\}A%.Î´¸" *',ZËeÌÖ,^TÖ}¬Æ#'*)!G;C Ù+(" W <¦yÑ=Jf¬©  £¨Ô­% $* Ô­ %( £ OÈÚÊ$)¦{A*º¯ * ) ,²No $* ¾b¥£ÈÚ,¦ ÕÅ¾%dl qÎ°¢%ÕÅÁ²,>#Íe*¦Á Í" ÂËiÓZ­­"# It+¦Á ¡"("
%%\v ~w(#£¨¸=')%%ØÁ#$* Ô­,Í# I¼~l,²)   
 *'½Olg·)Å
B#gc&ÓB ¦Á  $* TÖYÐ)ÈÚ%ÂJKÕ¥£²´®²)
 sqFk(" ¥£ÈÚ,²)P' G4CG= d% "Ú ,ÄQ­¸l ÕÅ o,¨tjÜWJo)'°{Å 3 $* TÖh¥£,²)   "$* Õo gµ "$* Ä¬oÒ(FkÛ P("¨tu**¿¢'¥¦%mÚÊA|­Ql)¦{lP  

**,Ä

.9>.'C6G:.=)×ÈÚ& _(" £¨ÍÌ³ÇF.B4CG: 46 OÅn½O±6»K}Ø*uÆ¹HO|nKe*jeÕÅ½O£¨*Ô­½OA0F<=e&"  gßg)K7(" R£))ß ·l +'－ 111 － ¶O\v l o r eº("%*0,42,,77*.,®¤#,Û)V  ¾¿) ¦Á  `¼~ÔÇ'*Ö$f¬§p*b{mÚh(¯ s'*¹Z ?F:Ä(q' ¥£Ndl´,²)   ¡
 ¼~=h(¯"*)\v&TN¢ og·("=EA(f¬Pa)  ^"©)Ä¬oÒb{U(mÚØ,ÆÊ¥£$* x)¼~ª 5³ _ )^½O0?G ºÊ#
sqFk("O ,l Ô­ )&&¾bÙ'q,)   "ÈÚ$'

)

[©®\v r
""8G4%CG$* ¾b'(ÈÚÊ²)
 #
 o,µ ^

**ªX¿¿¢ A  $ºq"2G=F
0.EGPv¼Ía¥P[¨s`PTÖYÐÕ)ÈÚ,¦Á
¼~)Â£,A 
TÖÏ©DFÅdl ¦Á   ªX'|­%mÚ¢ya' $* '(¥£ ª '^q
j8G4%CGÈÚs%N&h(¯,&)
l´ µ¡
**ªX'lÍ,l ­½ËÉ 
ÈÚxp ¦Á "－ 112 －

  "








Üw'*¿[,Î("-"HÑU(" w'*¿,""Î("¢ ¦Á 

ÝxÙ}gc¸Þ f¬P,®½Á*¹H *)O'F Ø f¬¥X[¨W°Ø.9>.£¨°Ø! yaN ¦Á " >@G)F -! ·,¦Á )&Fk)
 TÖÏp*×ÏpB
#¾M>$*"-9t
"AFÏ`":B·Ä¬$© )ËÉ ¾£$q" Ô­º^^ AF:,©X=Ó®® ª'*>^Õ )j©): )  Ô­S)9G6h,¼¨W£¨,J#),kh%\vÃ ² !  Â9±Ø×|#'*)D,#)×
R,g·#* &+' »KuÆ×|#'*) "$ Qb,)# $ ¾t Y,¢ystÔ­ª ¼
 ~Y¯®Ô­½Á,¼)OId)X=¾|*)9
G6%IÐ,Ô­½Ák ¼[e * º X=
Id¾9G6´,h(°* 'Ô­G($G(xp SØX=Id,¿½) )9G6,h(°X=l*¿=J¡,|#'*) ) ' 60,·)IÔ­S):ÕIdHI¿ÊÏ¾)# ½OÔ­,¼×D®T=E4:´º©,D¼ " %
(TÖc¢ Id½O,>#  ½O,+J{¿HI,K Ø£#+½OÔ­x)·¥ÍÙ .
" |¥Ô­) $*  9FD .Î%.¿"µsÄ|8,-¢®) $* * [¥ Ø$+'.Î%.¿|89; TÖ>f¬b{=¤#T\K
e#Øs)" &§t#^ Ml).Î*µsÄÍ) $* KT\ & '³ÇSØ£(T\st­v¼,[¨T\[¨)&(~Y®T  À) (°,IØ+,Á'*)
Ý',+ ¶Æ¸Þ $* »KÅ°Ø,) % _Ô\ßO»Kcl¾

－ 113 －

 Id°Ø¾
  Jo b{´}*.=9G:£Ï`$EGZ¼K7ÛÈÚÁÑ
-K7Þ

 ½Oe#WM oa ©Ñ_x¡ ÐOjmÚ }Ø90F t¥9G6IÂ99G6Ð¤T ¦{|#'*)+' <¦yÑxpÜ£¨,rZ<¦yÑÔ­8=xp'<¦^Är)
 $* ¬l)$TÖYÐ¿Ê _ÐX=1F
DG;$ Id·Q]·,* 'DF' ¨W±Ø90F $* Å)Qf¬PHÑÅ)$* =@)¥\QbX o53@B8/ xp½³¥\tÎlX´Þ ~YaÔ$¿]Â9,&¼Í#À¢NÔ­  ,©)X=g}º#ÓÕTg%Âc9G6J× ¾) O* Ø£³*)¸92>
GLe  o,GhSØ,#)£ ! $* ½Ox½O'Â9' +'Ä%7X=®7) Û`  uÆ,~
)&q·C * T\Ô­,Í#)?B:s'*Þ uÆ´ITÖÏ©"Õ d¹G$EG,¿¶Ô­·[· TÖÏ© º©^ Ø o¦®"0.xp&9G6h( 9F6(Ø¢ rs)Ô­ªQJÕ,&·ª,! .09.   Õ  '¾|KÕ$$qe)+Ó¾ o,[1'¼H $* ,Ô­)&,3896, O$^ ) '4R #,.91*846= À¢'¿=Ô­"¨W±Ø,¼)´,±J#,= ·#,/2+967,2,38 $Ó¾(" !1*8-462,6 ®·' #,/2+967,2,38 ²±)&(&(9;Ù $* ,r － 114 －

!1*8-462 "  !1*8-462   (ª *"C
. ' ' 43972,6 &(G(%nD.=B }À )ÆÊ $:W=Ä¬oÒIÂ9 K.¿ 
 TÖJÎ*)Ô­Ö¤#¿`( 
 $* B"AFÄ²e&%TÖ¢q.¿lIx))Q) 

~*

 9G6ÕS,_Ô)£¨Ô­¸¤T ÈÚ·" NQ8G'$) k)9G6a$*  IcÀ¾·)#©Ä¬oÒ.¿{lI f¬P¬lØf¬Pf¬PÕS?B:´  'ÌÇ® om,)$&;4´Ô­£¨
[1cl¸¤T SØ  'Â9: )+' WM oTµ%0;A0FJsË9G6J×,¼3G(,` %< TÖÏpK7 y.¿:
96,55  ½O¦)IPc  ¦ ÜW½O,^X=) ²(
 »Kxpn°Ø_Ð)#YÑF C´,¼.Z Ô­º©
»Kº©IF Cº© 'TÖÕ)¿ )#J¡¿Ê rZ 'O)#* ¡$$Jo¿Ê#* N), $ËÉ*Ä(TÖYÐ).¿ Û0G)Fx)Â9Þ ÈÚ x·¸qyÔ­Í"AF ( '9G6@t¤T$¿Ä  *()n,`)
 *t¼Õ£f¬0¤lIv¼cÂ9* K7" FGO($Í Ï'*)#
 2=:0FkhÃ©IØ OªXAk£¨Aka©_'9G6.45t ÏZ*)J7 k®Â9»KÅ#¨W
Â9kH9G6.45  $rId"HAk£¨£¨, * Á )$* t¼£¨¿À¢'$&3p)f¬Õr － 115 －

 Ä©.* ¨Wfz»,|#'*)X=
-& ±Ø¯®"0., "_Ê)  ¾ß¯®¥/)XÙ )
 TªÐªXFGOÔ­+" FGM
×#¯6(l$+)M yM×#¥/" =EA'G»¾b%Ä¬oÒb{ oA)ÛJ'²Þ) Ø s½Oe#Ô­Mp,0*)Ô­º )
 ±Øº©Õ sFº%*)  TÖ¢q&)f¬Õ
H(Ê SØ)  ·¥f¬PÔ­°Ø  c! '&¾|KÕ )ßTÖ¢q &Z*)¢ r ÖuÆTÖJÎ"Ä¬oÒ#)Q®¢v;,¯Z)  Ø
f{ Ù#OJ¡.¿,Ù#)#b2 ¾( ¢s ÈÚ)·";07 / )Ïb{±¼$ºq" ,¦).=BG)F£¨,¼" N»KuÆ,¢y·O-=/}Ø¥¢Ø·(fe-=}Ø
,Â"X=)Q®Í#+'  r "ÍÌ*£¨¸¤TN (" $* Ô­R¾wP¥$r f¬P© $}Ø ¾)
·_º©,^^  9G6@t$kÛ2=:0FÞ ¾)º©Õ¢Ø ) Â9Õ$x·°B!
'¾| Hs)  )  >Äom=EA(uÆÅ¨W®5³ *,[°)
Â9±ØÕS,ºÊ ÈÚ)K®f¬Õ 0F5F8/TÖYÐ ¾ O Á)mÚ tP%
Ån ÈÚ $* IÃ¾µ !©®ªÍ=([Q>,
Í# # stÛftÑÞ¨'ÍÌ,¤T
MpÔ­§p,T  Ó¾)
 7 Ô­cl¸qkÔ­ÕHÓÔ­ÈÚÂc )<¦^ ¾)
 9G6,×#^,K)~_' 
("N{´i ! ¯*)& º© Ù 
ºÊ "-  TÖ¢qÔ­¾º©,QJ )m^¢q  _("-p9tX=$9´·]
*" 8(Ô­º*8(?F8<Fº©´H*&q"
 $* Õ)Ä¬oÒ)Q®Â9^i ¿ '"k,g/OÂ9ÕS$¿ 'Û.¿Õ $* 0Yv¼
2ff¬P$kq"Þ－ 116 － ­½$ "&TÖJÎTÖ¢q&KsmÚ"*0,$Ô­,¤TÖJÎÛc¢Þ 0;A0F * Ô­º^^%Ô­@GC® ª% f¬[¹¯cº,s[¥:)q+*"  Ô­¸¤T Ø»Kª Ä 
 TÖÏ©.¿: }Ø®t®,°)#
9G6q r ¾º©Õ ()
 x·)q $$yX=¨W£¨B¼$  q ¤T  Â9 Ï`)+ ·¥\ =E:C´$¤[ËK '* $()Â9x)N® $ D ).) TÖ¢q,Q¬ QNQ $GA($ËÉ Ä($* J¡,·X=ÆÄ)  ØfÓ¾ÈÚ·)
 »KuÆ)Â9±Ø%ÐT°"TÖÏ©Â
9*$WËÉ ¾)¢ ÈÚs(" " $* Ô­f¬PÕÅ¾¾|KÕ ¦Á n)¾
g@¸$'*)ÆÊ(*'x$HZ¦{AÄÆÊDC£*)&ED ¾s) " ­½¸' ­­$Ki" TÖÏ©Ï'*Ì,_É)(¡Í)?Z{D_É*) $(R$-$c´,) SØ)¥£,¦Á¨f¬ÕoW¸ÕI5¢,¿^  ÈÚs(" TÖ¢qÜrZ*)sTÖ¢q $Id  g$Ô­º©
QJ )#  /Ü(P,z»x·}Ø, ! '|³*) Ô­J}¬P(e±Øl ("}ØÕ$7q$0s) 'TÖ¢qK(ª: Ù# Ð)Ï`k,'*f¬9G6,a © ))Q®, Â  0;A0F´,^ $ T
f»O*f¬PÔ­f¬9G6,a ©) T[Q2=:.1:
[e )&¾b,X  ·¥\ $* uÆ,',7 "RQ ' _?$' o.45 -t, $*Å°Ø)$'$$* ·QÄXS Ô­O¢
(g·  MTÖ_JÎ*X=¢q: +O"Id$f¬Õ?B Mp¤TO-$sqq"   ¡¢¿q}¬om©=EA(  TÖÜ.¿
$* eÂ9¹  Â9ÜÔ³Å|* & /¸ %) +'! '$K7(½－ 117 －

  ¥Ö}¬©.®Y) $* ,4R0*N[Â9,¼TÖ¢q¤T$>#[Q:GBGªÔ­Õ´ Ø s"  B# $* Ô­! ÈÚs("  TÖb{ ªÍ&Í# &_'1!1&) s   FG»K Y,j©*¹)  s Ì1)
  ´,© $* Æ°D  uÆ" ¨WB4
GÉÄomÁÊÈ4A@4AA_*)  Os ¯c"

$GA(ËÉ*(W &)9G6@tØTÖ¢q.¿ Ô­ Í"¾-q" Í¿=H(I)¿(Ô­[e+S) £¨Ö9G6Ak£¨¤T
¤T ÈÚ

)½Oel9G6

 }Ø)º© ¦s) /O-=¨W£¨ ¼
 "<¦^6*P ·¥ TÖ¢q h*z )_'"Mf¬a¡,)fe=8G4%CG5;$oÉ  »K=E5IdO¢°ØAH¹e  T¢qÅªqQ:¢,Â9"  ÅÚ$Z " .¿TÖ¢q»KÅ|#'*) 9FJ×#bq ,"OK ª)M ,|#'*"!G;C
'* Ô­º$@*)#
}A,-"Û * $* Ï  Þ  =EA(Qz»6(% qk% G% Ë e$s6(=EA( * fe=·6 ))  ¥¼b{[ Èb{Ã©* O=uÆh+Oe)?B:¿=Ù )   Øf¬PÔ­ ' 'f¬P+*uÆhlÂc. ¾) .¿TÖ¢qÔ­,¾¿)¾-)
 »KuÆ,h)#¾Xs)

¤#tk(Ñ_r 96C 08/ 0)%(V[M ".=8/
Ô­*AsÔ­,¢y  sqTÖÏ©)G$EG:,"G $s` Ô­¢·,g$s`s" Øf¬P$TÖÏ©－ 118 －

x·Y$$([Q®¯,·q" j®F ^"RÀGId$³8: )

－ 119 －

  



Üw'*sr[,Î("-"HÑU(" w'*sr,""Î("¢ ¦Á 

ÝxÙ}gc¸Þ °Ó o, (  " T\dX @BF4)J~YAk£¨%~YÍ^,NÏ³¾b
( (" =k9/)FJÐ_1`($(sq¶ " $:'!!% ´g$')_(% $ " ½³
$')¦Á Í%si " ,²*) " ,¦Á "" ,Å*)yS)G  ¼~=$¼m*)Ûb#'*)Þ=¦Á,¡#)N$,¸Å=)X¾,­+*Ä()=$*,~)
ØX¯Z,× ÀP$sq¶r  oL N$±,×
 TÖÏpÈÚÏpDFId)mÚ¢Øf+
(% ²Û"  ¬HQ$GA(gc   Ô­w(Û53@B8/¾2ÙÔe9"0ÏZDÞÅ$Û)
.("
 f¬PDT×= ¾·" $* ¬l% PÈ )¿) ¢H{  %A &·)ÕS¸,XÁ² X,$ÕS¸¦Á ¡"(klËÉ :)ºq "A)×ÙNf¬P&)$>#* V



ÖuÆb{~YÔ­*¨WX©*)ÜÞÚØÛØÝßÞ
$Ï©)¤Æ  ZÍ®»%(~Y$G'ÍÌD,$Ô­*dX@*$OP,)¸-$rq"ÜÞÚØ$®T%;07Í
QJrÓD®0 [°*)$ rq"ÜÞÚØ¨ut$GA(O,,|ËÉ*)&q+*" ~YOR¥dX¸N,g(ÜÞÚØuÆb{ jh#L¿   r¨,¹)À¢'~YO'g@$¾q"NÂ )&×" ØfFk("$* f¬P TÖYÐ*) YÐ9tOØfÓ¾ & _(" TÖYÐ*f¬P[ Ô­:¿=H*)Ï'Â9.¿`f¬P,f¬¸%Ð"¸ ±$B&*)s" $* g@)O$)#f¬P¾b§p,²I－ 120 －

k $* p² ¾q" oLP$8
G4%CG gc*PÅ &
 NQ$Øf¶ o,  ­(  " *  oLPXLo (F¸[*
gc)K

Q$& ×I" *Ï$Q­(" ¥£ $* Õ+)jO%TÖÄ¬Õ)[QÈÚ´,}#)K ^sqFk("   !$ "  _?
Z,@*× AG ½³*#" Õ 0" :8(s}P¥  [Q®¶Å[× X$ ¸*)°,¸Å$°Ó$* ÈÚ"r ¿K'*" Tom$Í 'T{Gs¸) G 0) ,(" $* Õ)b{¾f¬  8(%8(0F$A
K,lÍUD)s)$* }¬.1:(lI,¢y$* [×¸f¬G#£¨Ô­ª
Kª,¤ImÚ)¾b)¯¾,! f»O+}¬("¢ l'*)$* $}¬t,|8 )$* K®-Ø
'a»)*N"Ä,}º¦{dX¨'¾N[ Ù s­¿s}¬= n.Î,¼XLE,¢yf¬Õ0¤e%fe¯cº,¢y$(®f¬Y{ Gf¸*¸*f¬Õ*fe'oW,¼$') ,¢y! ("UyØ%R'» TÖYÐ ¥£.Wf¬,9)Ä¬_M± "£(®f¬º,lKaÔ,¼$
q "f¬ o ©Õ$8(a©¸ 8(Ã©
:,oW$* 8(g(º,@±'  ¥£? $G'½»OUyØ%Uy$G,l)$
## q,Tg)#G3FF¸ o  oW
F64: :£¨%}Øgc%Q»Ñ:)')
'Uy%R'»£¨Ô­%»KaÔ¸=ÐÕS Ó¾(2=:.1:£¨Ô­,Z"Í#) ÐÕSQe
$ ("%Å of¬ o9; #Å o¾É]WM o)Ï(s&F G1Z*)½»¨a©9;
·'*)¢1Lcb o*GLcb ob{}«,¼$¼
mÚQÆ q+*) D®}¬» ÄEG"C$N ·f¬§p,eÄKÓ ¿Ê#   %¥PÄ¬oÒÅ|DÌD5=: o,½»O
% $* FG»9Z%DFÅ © )b{,q):© Ù·) GTÖ¯=Ä¬oÒ9G6,{a©
)  ÙJ¡,) '$GMU)¥PÄ¬oÒoWDÌ$  $ '$ Id)#'$ 8(,©D5=:9
G6_q,c)FG,¹) K¹%½»¨[¸)·)   igm&(]ËÉ%&(Àdl,Fk &[$GA(－ 121 －

s
 n¤Z\v$r  &$GA(gc²Ê,¥"&P 0) sqØ q("Ý',+ ¶Æ¸Þ JÐZiÓ+(% µ ,®¤ )
Q$Ø×
 ­½\v!F;.1:H¤)$).("  $* Ä¬oÒ$%:ËÉ *$¡ *"$*  ,:,145,6 P¥ &(u %)*&q" WM oTµ$>#sqFk(" iÓ ÅÄ)
 TÖÏ©)Q®¯,ËÉ Í,K,ÉT_(%qk*Í]ÉTÛ)(  ÆÍ, !   f¬9G6a ©lK¸)Q B.Cgc,×oLX¶ l¥·) ,&NQÅ'*),·)M
$* Å s X=·)  r)
 8G',  =ÂÉÕ,0% ¶

$GA(

 # C9/)F&[9DG6G`()s" JÐZÍ¼?F:\@60>F%\v>#Øf_(% $Fk("¨tuÅn$GA(°Ó(¶ ¿ µ" ÕÉ_$ {& \v$&[q"N$±* (  X Æ(  " NPXgc )Mq 0%)&) ,~" iÓJÐZÍ# $_(f º
 ;,+ kÉÛ)Øf.(" JÐ-¼p­Õ+(%ØfÙ$Q$¼p－ 122 －

­*)*"

ØÕ,Hsq¶Õ,( $* Ô­&Ä¬oÒÀ¢'ÈÚ,¦Á(  ""¶Õ, TÖYÐ$ $* 8GÈÚ )s"uÆÅ$kq"Øf¬P½Ox)O¼T°$ÈÚ·" ¸7/Y("  &Õ$l`´X,¯ZÛ)Øf.(" Æ\v*ÕÉ_$&q" sq( 0F:¦Á" I ±© q" ¦Á Â_$r("ËKÈ®$ËÉ,"#w,ÉT)&(¦Á ¡")q"Æ,[e (  " Ñ ÑÂÉP $( N$[e*)×gcq"& ×¤"

 TÖYÐ#G:,$\v'K
=ÂÉiÓJÐ- $+(% "# *q""~¼m r ) q\v$JÐ- ¥X£$·]Á²$Fk(" Ï'*ÕJ\v=EA(,(U 

"Q$Øgc $* N$+JÂ*[e)84EG(d¶ )442 gc sq*¶ ¿Ê-ËÉ µsqg·(" b{¯®Ö Øf©c<¡ÕÅtP$ o|8,×" ©Çb{Ã©´,|k"  ""([1$¼$-)#S $GA( ,4E·"
 4B.("(  " Ò@sty Z ­½¥X
 ¶

0;)9G6|8[,²)

 $* &feÄ¬Õ £*)X=l¬tvYÐ9t, $* &'g* f¬Õ= $* =@0F5F8/ "*)
q"Ä¬oÒ $* a©( '$k9tTÖYÐ) $* 9t¹HP¥f¬ÕL}* &!TN )' -'xp ¾$*"-  sq# ¬ÑiÓ ­+*&µ *©Ç4
'+©Ç r Øf| -©Ç_Ð® ©

－ 123 －

Ûr"#K,o¿'*)&$')Øf( $* erÙ&( ¿, g·(" j=D F )Q®+(% ÈÚ´,s)   " 
 =D F6G -Ï'*Õ\r  o,&*)=DFÍ GNQÍ,1FEG; º µ =&0F:,%  )&b2
 
 PÍ¼ Øf(G %ÔGÙ:AC  '2
FA0Fgc$:D gc)   "  ¢dÙw'*¼mÙI½³"¾¢,¿
Ë 'ËÉ,µ 2FA0F'a¢ "*)q" Øf¶=)\vsq¶ N1Lcbf¬ odl¸N,g"ÐÖftÑ¨|n 'f¬oa © 8( ,6 Nf¬mÚ¢Á:x)·(" ¶ÆÛ (  " ¨utÕSj5K)q" ' ËÉ,ÓºlÉ=Û q" ÛÚ×9/)FX º
 WM o+f¬Dl_().("#0Fdl,^ f¬WM9G6§§''*9G6Áq&(}¬%ÄK¼
¤** ¸- }¬%T{ G¦$/G;"4*)$q" f¬ (He ØfÂ*)=EA(f¬ÍzÙ'$f¬9G6Hea©:Í'*'q¬ º¢­­\vg·(" ¢ ­­\v,9gA0; ÛMA0;a©sÞ £¨Ô­¼ ~Y=EA(f¬P=@,Â)O
?)=@lÌ1 )#s =@)#»K®oÄ¬oÒb{Nqe¸N  "- &PÓ¾
o·"N$& ×" ,QÂÉsMqsq NQyMq_*($µ% QÔ#$s60>F[eÛ) ,u
(" $yÕ,¼$'ÕbÏÆ¸ #²+s ("Äf ß _Æ_Hq K,D@? ÉT*¦Á.&q" "È$,'*)&).("& ×－ 124 －

" JÐ_1¦K"# º+(%Ø "TÖ¢
q K ­a&ÓB T¢q $*%d¹ $* $º'%I $* -0"¹H½ÁÄff¬P½Á¹H¸kD $* ½Á¹H¸© ! ´ º
=ÂÉÕ,r Û¼m&*x)Q­µ $¶s"Ô# (  " $GA( =ÂÉ9G6 ^$-f¬=de,ya'* f¬=n - '#n,H]9'^ ¥[$$!·Q ¾É]WM o"#1Lcb
$,) 0;A0F  )l( "WM® FG=de$?,@*Û qÛyZ$" 9G6^"-9G6^D $ 6
"-*5º© (")FG-$*(')Þ  OÛ (  "Fk(gc&',+ $=+
  L¦{gc*)µ "* -¸N):4
8 " (_?\.Û¼~f¬Õ£¨ÕO´OX=fÅP*6G:.=´Þgcz¤1]{)=ÛN $* Ô­Õ+)NÔ­,Â) *¸Nµ)´Þ,²(q"N$ $GA( )X=4($Û)K Ä¬oÒ¯ZÈÚsqFk(" Õ Ï'*)$&( -$&q"9/)F'Fk¾_$(" sq%,K"(  "  ¿ (sqFk)P $FÍ,6)I&
RQ|#'*)$ZÛ[¥  $Þ¿¢q '©·,' Y
w" d¿("  ¥UPËQ d)J
TÖÕ) ' ª I$(½*"  N$Z®¿LP)ºq"JÐZ-)K$.
BF,)Ó¾s"H-)OM"0.&$,cNI, x |#'*)
s" ØfºÆ9/)F  ¸3_X "$ ²c¼mx$­[Q­ $g·("(  "
 H8G'Û$* lÍÞx# AGÕËÉ,~

－ 125 －  f¬ ¸~z!+® -7 yÅ (!(¢*mÚ¢ Á(" "NQf¬ZK¸ &G:=Å r ¼dqv.=BËÉ y¼dqv.=B $Qh(Û* V  0;¢¿Ê, )K q"  ÛÞ7/*°¨)C$:1 . ~)$ 9Þ7/*°¨)}¬©.=BG)F~)$ :Þ Z 4A?)K7I #  $* 4
A@ ¬l ;ÞT\4A?f¬P=EA(NaÔÛ¾¼~¿ÁÞ   ¨utÅnFz¿¢lØ s"I ± $* ½
O*=EA(f¬P,+z#)eËÉ´,ÓÛ* 
M"v¼ +z ) ,~"·É ¸q"  NQ&Æ¶Æ¸'¼m# B:·,L60C(" ±Û'q"  " %¿L$A2)K Ø\v$r   Qr* WM®º
 ""¿L,ªX·¦Á,¡#£q"
 $&[\v(¸N¡5><G
 }¬%Ämom=EA(\©=EA(ÅuÆÆ°(,]·
! ·) G©. ¢®)oq´6BF:DGF(´º©*)! =EA(,f¬P) ¾g@SØ) "Øf¬P Z9G6,½³_q) =EA(f¬P) ½³ oN )m )H¹º¸f¬P'" f¬P Zf¬P=EA( ½³_q ·)
 b{»K C"'ÖÏ$)q" ¼~[1DCxpÈÚÆÊ$)l ¿¢# AGcÔ#,U"
 ÈÉ,U"  9/)FX (©*(Í¼s¤"ÛÄf*
* ­­ -¿LX   rÞ  9G6a ©Õ¨W¥X' i¦Á,z).("N # ´,=@*)stÐ´Å µ'ºq"  ­½©*=DÛ 

F8G)F

!F;.1:)#,ÉT  $GA(ÈÚ,²)  " Á3_$
GA(XÁ,³ Øq" $GA(－ 126 －

ËÉ, Á ³*)&$Q06$GA(wo?   »KuÆx1,©')·%K7$Yª\v
 ¸¢¡ª2=:0F  &X=£¨#Äf¾>9G6" h'*7f¬º ­y"" ¸k""f¬9G6 )& f¬Õ= O'Ì,×#)#f¬ºr 9G6,h Ak£¨,L¢£¨ ¼+*)
$^ )*$)q+*"   ,Í#) SØ ¦Á  f¬Pn+)$$* ,N&h(@* ! ,·)BÖ
&P * gcq"h(¯Jb{X fÂ*)¿"  *¥[dÈÚ ¿ ¤$3µs xp )&Û)º  N d%f¬Õ' " Y_Ë­¥[#xp,

)}Ù,)G( Õ " ,  ¡"Í,|8Ût.("s1"  F&1(9/)F º  60(BGOq" =EA(f¬PaÔ&
f¬++ Ô*)q"Zf¬DN
'-*):
,)#"ft(t À¢V±,a 'b{¯®,¼  ×"  ©/Á)M$r&s"   +Â*&)#$ &h(¯,±s`q"O*Ã,,(  "  2F9/'F;É,× q" # C9/)F Øf¶
 Í,K,.("**,& ÄÊ-'gc) s` *5><G("-'­ )­&(H,k Ñ_ s q" K,¿¢,¿ s`K,ÉT60>F (  q" Ø$gc\v l1+xp @(sq"N'd¶"-5 d¶Û))Í,d¿Û)´$ "-ß¥UA  w,aÔ¥P[¨,Í#)#IÃ " 0Õ¢²Ê,Û `×(R  ×I"

& $GA(,Ô#f¬O¼lIED )-#*Æ

－ 127 －¸ o's1I" (  " ÕÅ)j_ªX o|89/)F,d¶ Øf¶
Q¥.gc/L,  $* TÖJÎÕ)ÈÚÁ $* ¥£Qa,¦Á)   "N$Íz£ ²,~("/Ô#Õ)s1Q­
Q­  2 w'* 2Fk#N±,~)

－ 128 －