Source: https://www.law.cornell.edu/cfr/text/21/part-892/subpart-B
Timestamp: 2017-12-11 04:10:56
Document Index: 181882538

Matched Legal Cases: ['art 892', 'art 892', 'art 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', '§ 892', 'art 892', 'arts 876', 'arts 876', 'arts 814']

21 CFR Part 892, Subpart B - Diagnostic Devices | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter H › Part 892 › Subpart B
21 CFR Part 892, Subpart B - Diagnostic Devices
§ 892.1000 Magnetic resonance diagnostic device.
§ 892.1100 Scintillation (gamma) camera.
§ 892.1110 Positron camera.
§ 892.1130 Nuclear whole body counter.
§ 892.1170 Bone densitometer.
§ 892.1180 Bone sonometer.
§ 892.1200 Emission computed tomography system.
§ 892.1220 Fluorescent scanner.
§ 892.1300 Nuclear rectilinear scanner.
§ 892.1310 Nuclear tomography system.
§ 892.1320 Nuclear uptake probe.
§ 892.1330 Nuclear whole body scanner.
§ 892.1350 Nuclear scanning bed.
§ 892.1360 Radionuclide dose calibrator.
§ 892.1370 Nuclear anthropomorphic phantom.
§ 892.1380 Nuclear flood source phantom.
§ 892.1390 Radionuclide rebreathing system.
§ 892.1400 Nuclear sealed calibration source.
§ 892.1410 Nuclear electrocardiograph synchronizer.
§ 892.1420 Radionuclide test pattern phantom.
§ 892.1540 Nonfetal ultrasonic monitor.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
§ 892.1560 Ultrasonic pulsed echo imaging system.
§ 892.1570 Diagnostic ultrasonic transducer.
§ 892.1600 Angiographic x-ray system.
§ 892.1610 Diagnostic x-ray beam-limiting device.
§ 892.1620 Cine or spot fluorographic x-ray camera.
§ 892.1630 Electrostatic x-ray imaging system.
§ 892.1640 Radiographic film marking system.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
§ 892.1660 Non-image-intensified fluoroscopic x-ray system.
§ 892.1670 Spot-film device.
§ 892.1680 Stationary x-ray system.
§ 892.1700 Diagnostic x-ray high voltage generator.
§ 892.1710 Mammographic x-ray system.
§ 892.1715 Full-field digital mammography system.
§ 892.1720 Mobile x-ray system.
§ 892.1730 Photofluorographic x-ray system.
§ 892.1740 Tomographic x-ray system.
§ 892.1750 Computed tomography x-ray system.
§ 892.1760 Diagnostic x-ray tube housing assembly.
§ 892.1770 Diagnostic x-ray tube mount.
§ 892.1820 Pneumoencephalographic chair.
§ 892.1830 Radiologic patient cradle.
§ 892.1840 Radiographic film.
§ 892.1850 Radiographic film cassette.
§ 892.1860 Radiographic film/cassette changer.
§ 892.1870 Radiographic film/cassette changer programmer.
§ 892.1880 Wall-mounted radiographic cassette holder.
§ 892.1890 Radiographic film illuminator.
§ 892.1900 Automatic radiographic film processor.
§ 892.1910 Radiographic grid.
§ 892.1920 Radiographic head holder.
§ 892.1940 Radiologic quality assurance instrument.
§ 892.1950 Radiographic anthropomorphic phantom.
§ 892.1960 Radiographic intensifying screen.
§ 892.1970 Radiographic ECG/respirator synchronizer.
§ 892.1980 Radiologic table.
§ 892.1990 Transilluminator for breast evaluation.
§ 892.2010 Medical image storage device.
§ 892.2020 Medical image communications device.
§ 892.2030 Medical image digitizer.
§ 892.2040 Medical image hardcopy device.
§ 892.2050 Picture archiving and communications system.
Title 21 published on 20-Sep-2017 03:51
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 892 after this date.
79 FR 3088 - Effective Date of Requirement for Premarket Approval for Transilluminator for Breast Evaluation and Sorbent Hemoperfusion System (SHS) Devices for the Treatment of Hepatic Coma and Metabolic Disturbances; Reclassification of SHS Devices for the Treatment of Poisoning and Drug Overdose
FR Doc. 2014-00873
Docket No. FDA-2013-N-0195
This order is effective January 17, 2014.
21 CFR Parts 876 and 892
The Food and Drug Administration (FDA) is issuing a final order to require the filing of a premarket approval application (PMA) for the transilluminator for breast evaluation and sorbent hemoperfusion system (SHS) devices for the treatment of hepatic coma and metabolic disturbances and to reclassify SHS devices for the treatment of poisoning and drug overdose, a preamendments class III device, into class II (special controls).
2013-04-04; vol. 78 # 65 - Thursday, April 4, 2013
78 FR 20268 - Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices; Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose
FR Doc. 2013-07730
Submit written or electronic comments on this proposed order by May 6, 2013. FDA intends that, if a final order based on this proposed order is issued, anyone who wishes to continue to market the sorbent hemoperfusion devices for the treatment of hepatic coma and metabolic disturbances; cranial electrotherapy stimulator for the treatment of depression, anxiety, and insomnia; or transilluminator for breast evaluation will need to file a PMA or a notice of completion of a PDP within 90 days of the effective date of the final order. See section XIII of this document for the proposed effective date of any final order that may publish based on this proposed order.
21 CFR Parts 876, 882, and 892
The Food and Drug Administration (FDA) is issuing a proposed administrative order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following three class III preamendments devices: Sorbent hemoperfusion devices for the treatment of hepatic coma and metabolic disturbances; cranial electrotherapy stimulator for the treatment of depression, anxiety, and insomnia; and transilluminator for breast evaluation. FDA is also announcing the opportunity for interested persons to request that the Agency change the classification of any of the aforementioned devices based on new information. In addition, FDA is proposing to reclassify sorbent hemoperfusion devices for the treatment of poisoning and drug overdose, a preamendments class III device, into class II (special controls) based on new information respecting the device. This action implements certain statutory requirements.
2013-03-26; vol. 78 # 58 - Tuesday, March 26, 2013
78 FR 18233 - Medical Devices; Technical Amendment
FR Doc. 2013-06826
Docket No. FDA-2013-N-0011
This rule is effective March 26, 2013.
21 CFR Parts 814, 822, 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890, and 892
The Food and Drug Administration (FDA) is amending certain medical device regulations to correct minor errors in the Code of Federal Regulations (CFR). This action is editorial in nature and is intended to provide accuracy and clarity to the Agency&apos;s regulations.