Title 21

PART 892

Part 892 - Radiology Devices

PART 892 - RADIOLOGY DEVICES Authority:21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. Source:53 FR 1567, Jan. 20, 1988, unless otherwise noted. Editorial Note:Nomenclature changes to part 892 appear at 73 FR 35341, June 23, 2008.

21:8.0.1.1.33.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.33.1.1.1SECTION 892.1
   892.1 Scope.
21:8.0.1.1.33.1.1.2SECTION 892.3
   892.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.33.1.1.3SECTION 892.9
   892.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.33.2SUBPART B
Subpart B - Diagnostic Devices
21:8.0.1.1.33.2.1.1SECTION 892.1000
   892.1000 Magnetic resonance diagnostic device.
21:8.0.1.1.33.2.1.2SECTION 892.1100
   892.1100 Scintillation (gamma) camera.
21:8.0.1.1.33.2.1.3SECTION 892.1110
   892.1110 Positron camera.
21:8.0.1.1.33.2.1.4SECTION 892.1130
   892.1130 Nuclear whole body counter.
21:8.0.1.1.33.2.1.5SECTION 892.1170
   892.1170 Bone densitometer.
21:8.0.1.1.33.2.1.6SECTION 892.1180
   892.1180 Bone sonometer.
21:8.0.1.1.33.2.1.7SECTION 892.1200
   892.1200 Emission computed tomography system.
21:8.0.1.1.33.2.1.8SECTION 892.1220
   892.1220 Fluorescent scanner.
21:8.0.1.1.33.2.1.9SECTION 892.1300
   892.1300 Nuclear rectilinear scanner.
21:8.0.1.1.33.2.1.10SECTION 892.1310
   892.1310 Nuclear tomography system.
21:8.0.1.1.33.2.1.11SECTION 892.1320
   892.1320 Nuclear uptake probe.
21:8.0.1.1.33.2.1.12SECTION 892.1330
   892.1330 Nuclear whole body scanner.
21:8.0.1.1.33.2.1.13SECTION 892.1350
   892.1350 Nuclear scanning bed.
21:8.0.1.1.33.2.1.14SECTION 892.1360
   892.1360 Radionuclide dose calibrator.
21:8.0.1.1.33.2.1.15SECTION 892.1370
   892.1370 Nuclear anthropomorphic phantom.
21:8.0.1.1.33.2.1.16SECTION 892.1380
   892.1380 Nuclear flood source phantom.
21:8.0.1.1.33.2.1.17SECTION 892.1390
   892.1390 Radionuclide rebreathing system.
21:8.0.1.1.33.2.1.18SECTION 892.1400
   892.1400 Nuclear sealed calibration source.
21:8.0.1.1.33.2.1.19SECTION 892.1410
   892.1410 Nuclear electrocardiograph synchronizer.
21:8.0.1.1.33.2.1.20SECTION 892.1420
   892.1420 Radionuclide test pattern phantom.
21:8.0.1.1.33.2.1.21SECTION 892.1540
   892.1540 Nonfetal ultrasonic monitor.
21:8.0.1.1.33.2.1.22SECTION 892.1550
   892.1550 Ultrasonic pulsed doppler imaging system.
21:8.0.1.1.33.2.1.23SECTION 892.1560
   892.1560 Ultrasonic pulsed echo imaging system.
21:8.0.1.1.33.2.1.24SECTION 892.1570
   892.1570 Diagnostic ultrasonic transducer.
21:8.0.1.1.33.2.1.25SECTION 892.1600
   892.1600 Angiographic x-ray system.
21:8.0.1.1.33.2.1.26SECTION 892.1610
   892.1610 Diagnostic x-ray beam-limiting device.
21:8.0.1.1.33.2.1.27SECTION 892.1620
   892.1620 Cine or spot fluorographic x-ray camera.
21:8.0.1.1.33.2.1.28SECTION 892.1630
   892.1630 Electrostatic x-ray imaging system.
21:8.0.1.1.33.2.1.29SECTION 892.1640
   892.1640 Radiographic film marking system.
21:8.0.1.1.33.2.1.30SECTION 892.1650
   892.1650 Image-intensified fluoroscopic x-ray system.
21:8.0.1.1.33.2.1.31SECTION 892.1660
   892.1660 Non-image-intensified fluoroscopic x-ray system.
21:8.0.1.1.33.2.1.32SECTION 892.1670
   892.1670 Spot-film device.
21:8.0.1.1.33.2.1.33SECTION 892.1680
   892.1680 Stationary x-ray system.
21:8.0.1.1.33.2.1.34SECTION 892.1700
   892.1700 Diagnostic x-ray high voltage generator.
21:8.0.1.1.33.2.1.35SECTION 892.1710
   892.1710 Mammographic x-ray system.
21:8.0.1.1.33.2.1.36SECTION 892.1715
   892.1715 Full-field digital mammography system.
21:8.0.1.1.33.2.1.37SECTION 892.1720
   892.1720 Mobile x-ray system.
21:8.0.1.1.33.2.1.38SECTION 892.1730
   892.1730 Photofluorographic x-ray system.
21:8.0.1.1.33.2.1.39SECTION 892.1740
   892.1740 Tomographic x-ray system.
21:8.0.1.1.33.2.1.40SECTION 892.1750
   892.1750 Computed tomography x-ray system.
21:8.0.1.1.33.2.1.41SECTION 892.1760
   892.1760 Diagnostic x-ray tube housing assembly.
21:8.0.1.1.33.2.1.42SECTION 892.1770
   892.1770 Diagnostic x-ray tube mount.
21:8.0.1.1.33.2.1.43SECTION 892.1820
   892.1820 Pneumoencephalographic chair.
21:8.0.1.1.33.2.1.44SECTION 892.1830
   892.1830 Radiologic patient cradle.
21:8.0.1.1.33.2.1.45SECTION 892.1840
   892.1840 Radiographic film.
21:8.0.1.1.33.2.1.46SECTION 892.1850
   892.1850 Radiographic film cassette.
21:8.0.1.1.33.2.1.47SECTION 892.1860
   892.1860 Radiographic film/cassette changer.
21:8.0.1.1.33.2.1.48SECTION 892.1870
   892.1870 Radiographic film/cassette changer programmer.
21:8.0.1.1.33.2.1.49SECTION 892.1880
   892.1880 Wall-mounted radiographic cassette holder.
21:8.0.1.1.33.2.1.50SECTION 892.1890
   892.1890 Radiographic film illuminator.
21:8.0.1.1.33.2.1.51SECTION 892.1900
   892.1900 Automatic radiographic film processor.
21:8.0.1.1.33.2.1.52SECTION 892.1910
   892.1910 Radiographic grid.
21:8.0.1.1.33.2.1.53SECTION 892.1920
   892.1920 Radiographic head holder.
21:8.0.1.1.33.2.1.54SECTION 892.1940
   892.1940 Radiologic quality assurance instrument.
21:8.0.1.1.33.2.1.55SECTION 892.1950
   892.1950 Radiographic anthropomorphic phantom.
21:8.0.1.1.33.2.1.56SECTION 892.1960
   892.1960 Radiographic intensifying screen.
21:8.0.1.1.33.2.1.57SECTION 892.1970
   892.1970 Radiographic ECG/respirator synchronizer.
21:8.0.1.1.33.2.1.58SECTION 892.1980
   892.1980 Radiologic table.
21:8.0.1.1.33.2.1.59SECTION 892.1990
   892.1990 Transilluminator for breast evaluation.
21:8.0.1.1.33.2.1.60SECTION 892.2010
   892.2010 Medical image storage device.
21:8.0.1.1.33.2.1.61SECTION 892.2020
   892.2020 Medical image communications device.
21:8.0.1.1.33.2.1.62SECTION 892.2030
   892.2030 Medical image digitizer.
21:8.0.1.1.33.2.1.63SECTION 892.2040
   892.2040 Medical image hardcopy device.
21:8.0.1.1.33.2.1.64SECTION 892.2050
   892.2050 Picture archiving and communications system.
21:8.0.1.1.33.2.1.65SECTION 892.2060
   892.2060 Radiological computer-assisted diagnostic software for lesions suspicious of cancer.
21:8.0.1.1.33.2.1.66SECTION 892.2070
   892.2070 Medical image analyzer.
21:8.0.1.1.33.2.1.67SECTION 892.2080
   892.2080 Radiological computer aided triage and notification software.
21:8.0.1.1.33.3SUBPART C
Subparts C-E [Reserved]
21:8.0.1.1.33.4SUBPART F
Subpart F - Therapeutic Devices
21:8.0.1.1.33.4.1.1SECTION 892.5050
   892.5050 Medical charged-particle radiation therapy system.
21:8.0.1.1.33.4.1.2SECTION 892.5300
   892.5300 Medical neutron radiation therapy system.
21:8.0.1.1.33.4.1.3SECTION 892.5650
   892.5650 Manual radionuclide applicator system.
21:8.0.1.1.33.4.1.4SECTION 892.5700
   892.5700 Remote controlled radionuclide applicator system.
21:8.0.1.1.33.4.1.5SECTION 892.5710
   892.5710 Radiation therapy beam-shaping block.
21:8.0.1.1.33.4.1.6SECTION 892.5720
   892.5720 Rectal balloon for prostate immobilization.
21:8.0.1.1.33.4.1.7SECTION 892.5725
   892.5725 Absorbable perirectal spacer.
21:8.0.1.1.33.4.1.8SECTION 892.5730
   892.5730 Radionuclide brachytherapy source.
21:8.0.1.1.33.4.1.9SECTION 892.5740
   892.5740 Radionuclide teletherapy source.
21:8.0.1.1.33.4.1.10SECTION 892.5750
   892.5750 Radionuclide radiation therapy system.
21:8.0.1.1.33.4.1.11SECTION 892.5770
   892.5770 Powered radiation therapy patient support assembly.
21:8.0.1.1.33.4.1.12SECTION 892.5780
   892.5780 Light beam patient position indicator.
21:8.0.1.1.33.4.1.13SECTION 892.5840
   892.5840 Radiation therapy simulation system.
21:8.0.1.1.33.4.1.14SECTION 892.5900
   892.5900 X-ray radiation therapy system.
21:8.0.1.1.33.4.1.15SECTION 892.5930
   892.5930 Therapeutic x-ray tube housing assembly.
21:8.0.1.1.33.5SUBPART G
Subpart G - Miscellaneous Devices
21:8.0.1.1.33.5.1.1SECTION 892.6500
   892.6500 Personnel protective shield.