Title 21

PART 892 SUBPART B

Subpart B - Diagnostic Devices

• 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
• 53 FR 1567, Jan. 20, 1988, unless otherwise noted.

21:8.0.1.1.33.2.1.1	SECTION 892.1000	892.1000 Magnetic resonance diagnostic device.
21:8.0.1.1.33.2.1.2	SECTION 892.1100	892.1100 Scintillation (gamma) camera.
21:8.0.1.1.33.2.1.3	SECTION 892.1110	892.1110 Positron camera.
21:8.0.1.1.33.2.1.4	SECTION 892.1130	892.1130 Nuclear whole body counter.
21:8.0.1.1.33.2.1.5	SECTION 892.1170	892.1170 Bone densitometer.
21:8.0.1.1.33.2.1.6	SECTION 892.1180	892.1180 Bone sonometer.
21:8.0.1.1.33.2.1.7	SECTION 892.1200	892.1200 Emission computed tomography system.
21:8.0.1.1.33.2.1.8	SECTION 892.1220	892.1220 Fluorescent scanner.
21:8.0.1.1.33.2.1.9	SECTION 892.1300	892.1300 Nuclear rectilinear scanner.
21:8.0.1.1.33.2.1.10	SECTION 892.1310	892.1310 Nuclear tomography system.
21:8.0.1.1.33.2.1.11	SECTION 892.1320	892.1320 Nuclear uptake probe.
21:8.0.1.1.33.2.1.12	SECTION 892.1330	892.1330 Nuclear whole body scanner.
21:8.0.1.1.33.2.1.13	SECTION 892.1350	892.1350 Nuclear scanning bed.
21:8.0.1.1.33.2.1.14	SECTION 892.1360	892.1360 Radionuclide dose calibrator.
21:8.0.1.1.33.2.1.15	SECTION 892.1370	892.1370 Nuclear anthropomorphic phantom.
21:8.0.1.1.33.2.1.16	SECTION 892.1380	892.1380 Nuclear flood source phantom.
21:8.0.1.1.33.2.1.17	SECTION 892.1390	892.1390 Radionuclide rebreathing system.
21:8.0.1.1.33.2.1.18	SECTION 892.1400	892.1400 Nuclear sealed calibration source.
21:8.0.1.1.33.2.1.19	SECTION 892.1410	892.1410 Nuclear electrocardiograph synchronizer.
21:8.0.1.1.33.2.1.20	SECTION 892.1420	892.1420 Radionuclide test pattern phantom.
21:8.0.1.1.33.2.1.21	SECTION 892.1540	892.1540 Nonfetal ultrasonic monitor.
21:8.0.1.1.33.2.1.22	SECTION 892.1550	892.1550 Ultrasonic pulsed doppler imaging system.
21:8.0.1.1.33.2.1.23	SECTION 892.1560	892.1560 Ultrasonic pulsed echo imaging system.
21:8.0.1.1.33.2.1.24	SECTION 892.1570	892.1570 Diagnostic ultrasonic transducer.
21:8.0.1.1.33.2.1.25	SECTION 892.1600	892.1600 Angiographic x-ray system.
21:8.0.1.1.33.2.1.26	SECTION 892.1610	892.1610 Diagnostic x-ray beam-limiting device.
21:8.0.1.1.33.2.1.27	SECTION 892.1620	892.1620 Cine or spot fluorographic x-ray camera.
21:8.0.1.1.33.2.1.28	SECTION 892.1630	892.1630 Electrostatic x-ray imaging system.
21:8.0.1.1.33.2.1.29	SECTION 892.1640	892.1640 Radiographic film marking system.
21:8.0.1.1.33.2.1.30	SECTION 892.1650	892.1650 Image-intensified fluoroscopic x-ray system.
21:8.0.1.1.33.2.1.31	SECTION 892.1660	892.1660 Non-image-intensified fluoroscopic x-ray system.
21:8.0.1.1.33.2.1.32	SECTION 892.1670	892.1670 Spot-film device.
21:8.0.1.1.33.2.1.33	SECTION 892.1680	892.1680 Stationary x-ray system.
21:8.0.1.1.33.2.1.34	SECTION 892.1700	892.1700 Diagnostic x-ray high voltage generator.
21:8.0.1.1.33.2.1.35	SECTION 892.1710	892.1710 Mammographic x-ray system.
21:8.0.1.1.33.2.1.36	SECTION 892.1715	892.1715 Full-field digital mammography system.
21:8.0.1.1.33.2.1.37	SECTION 892.1720	892.1720 Mobile x-ray system.
21:8.0.1.1.33.2.1.38	SECTION 892.1730	892.1730 Photofluorographic x-ray system.
21:8.0.1.1.33.2.1.39	SECTION 892.1740	892.1740 Tomographic x-ray system.
21:8.0.1.1.33.2.1.40	SECTION 892.1750	892.1750 Computed tomography x-ray system.
21:8.0.1.1.33.2.1.41	SECTION 892.1760	892.1760 Diagnostic x-ray tube housing assembly.
21:8.0.1.1.33.2.1.42	SECTION 892.1770	892.1770 Diagnostic x-ray tube mount.
21:8.0.1.1.33.2.1.43	SECTION 892.1820	892.1820 Pneumoencephalographic chair.
21:8.0.1.1.33.2.1.44	SECTION 892.1830	892.1830 Radiologic patient cradle.
21:8.0.1.1.33.2.1.45	SECTION 892.1840	892.1840 Radiographic film.
21:8.0.1.1.33.2.1.46	SECTION 892.1850	892.1850 Radiographic film cassette.
21:8.0.1.1.33.2.1.47	SECTION 892.1860	892.1860 Radiographic film/cassette changer.
21:8.0.1.1.33.2.1.48	SECTION 892.1870	892.1870 Radiographic film/cassette changer programmer.
21:8.0.1.1.33.2.1.49	SECTION 892.1880	892.1880 Wall-mounted radiographic cassette holder.
21:8.0.1.1.33.2.1.50	SECTION 892.1890	892.1890 Radiographic film illuminator.
21:8.0.1.1.33.2.1.51	SECTION 892.1900	892.1900 Automatic radiographic film processor.
21:8.0.1.1.33.2.1.52	SECTION 892.1910	892.1910 Radiographic grid.
21:8.0.1.1.33.2.1.53	SECTION 892.1920	892.1920 Radiographic head holder.
21:8.0.1.1.33.2.1.54	SECTION 892.1940	892.1940 Radiologic quality assurance instrument.
21:8.0.1.1.33.2.1.55	SECTION 892.1950	892.1950 Radiographic anthropomorphic phantom.
21:8.0.1.1.33.2.1.56	SECTION 892.1960	892.1960 Radiographic intensifying screen.
21:8.0.1.1.33.2.1.57	SECTION 892.1970	892.1970 Radiographic ECG/respirator synchronizer.
21:8.0.1.1.33.2.1.58	SECTION 892.1980	892.1980 Radiologic table.
21:8.0.1.1.33.2.1.59	SECTION 892.1990	892.1990 Transilluminator for breast evaluation.
21:8.0.1.1.33.2.1.60	SECTION 892.2010	892.2010 Medical image storage device.
21:8.0.1.1.33.2.1.61	SECTION 892.2020	892.2020 Medical image communications device.
21:8.0.1.1.33.2.1.62	SECTION 892.2030	892.2030 Medical image digitizer.
21:8.0.1.1.33.2.1.63	SECTION 892.2040	892.2040 Medical image hardcopy device.
21:8.0.1.1.33.2.1.64	SECTION 892.2050	892.2050 Picture archiving and communications system.
21:8.0.1.1.33.2.1.65	SECTION 892.2060	892.2060 Radiological computer-assisted diagnostic software for lesions suspicious of cancer.
21:8.0.1.1.33.2.1.66	SECTION 892.2070	892.2070 Medical image analyzer.
21:8.0.1.1.33.2.1.67	SECTION 892.2080	892.2080 Radiological computer aided triage and notification software.

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