10/13/2020

Public Enquiry - Singapore Medical Device Register (SMDR)
PUBLIC ENQUIRY - SINGAPORE MEDICAL DEVICE REGISTER (SMDR)

Device InfoDevice Name:

Anzai Medical Respiratory Gating System AZ-733VI [Anzai Medical Co., Ltd.]

Description:

Respiratory Gating System AZ-733VI is intended to be used with diagnostic X-ray or radiation
therapy systems to gate these devices on and off when target points of the patient’s respiratory
cycle are within preset limits. When an organ with respiratory movement is targeted by theexternal device synchronizing its irradiation with the respiratory information, that is respiratorygated irradiation, improved accuracy of diagnostic image or radiation therapy can be attained.
Intended operators are those who understand the operation of the system and the effectiveness of
respiratory gating systems. To help you understand them effectively, we are providing training
based on this manual. Intended patients are those who are to undergo image diagnosis orradiation therapy, able to obey the operators and able to keep stable respiration.

Medical Specialty Area:

Radiology / Imaging

Medical Device Class:

Class C medical device

Device Registration No:

DE0505026

Registration Date:

12/10/2020

Change Notification Approval Date:

Not Applicable

Product Owner
1. Anzai Medical Co., Ltd. [Anzai Medical Co., Ltd.] 3-9-15, Nishi-Shinagawa, Shinagawa-ku, Tokyo, 141-0033, JAPANRegistrant
1. EMERGO SINGAPORE CONSULTING PRIVATE LIMITED 1 FUSIONOPOLIS WALK, SOLARIS South Tower, #10-01, SINGAPORE 138628
ModelsNo.

Model Name

Identifier

1Sensor Port

400322-1

2Relay Box

400322-2

3Gate Disable Switch

400322-3

4

Personal computer

400322-4

5

Load Cell Standard

400322-5

6

Load Cell Deep

400322-6

7

Load Cell Fixing Belt (S,M,L,LL)

400073-36, 6, 7, 8

8Load Cell Calibrator

400073-9

9SP-RB I/O Cable

400322-18

10Gate Disable Switch Cable

400322-19

11Sensor Cable

400322-20

12USB Cable

400322-21

13

EXT.I/O Cable

400322-38

14

AC Power Cable (For USA, 3m)

400073-43

15

AC Power Cable (For EU, 3m)

400073-14

16

Screwdriver Set

400073-22

17

Laser Sensor (85mm)

400322-11

18

Laser Sensor (120mm)

400322-12

19

Laser Sensor (250mm)

400322-49

20

Laser Sensor Fixture (Type A)

400074-1

21

Laser Sensor Fixture (Type M)

400074-13

22

Laser Sensor Fixture (Type T)

400074-4

23

IRP Sensor Main Unit

400322-51

24

IRP Sensor Fixture

400322-54

25

Tablet set

400409-1

26

Patient Exclusive Goggle

400409-2

27

ABLE(Anzai Breath Learning Equipment)

ABLE

28

Tablet Fixture (Stand type)

400409-3

29

Wave Monitor

400322-1430

ECG Board

400322-15

31

Interface Board 1

400322-16

32

Interface Board 2400322-17

33

Wave Monitor Cable

400322-27

34

ECG Cable

400322-39

35

RS232C Cable

400322-40

36

Reflector

400322-5237

Tablet Fixture(Mount type)

400409-4

38

Bluetooth Transceiver

400409-5

39

USB Cable

400409-640

AC Adapter

400409-7

41

Respiratory Gating System AZ-733VI

AZ-733VI

https://eservice.hsa.gov.sg/medics/md/mdEnquiry.do?action=getDeviceInfo&devId=C502285F6333-20

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10/13/2020

Public Enquiry - Singapore Medical Device Register (SMDR)
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Last Updated 16 Oct 20192/2