2001 CFR Title 21, Volume 8

Title 21--Food and Drugs CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued) PART 892--RADIOLOGY DEVICES
	892.1	Scope.
	892.3	Effective dates of requirement for premarket approval.
	892.9	Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
	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.
	892.1200	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.
	892.1720	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.
	892.5050	Medical charged-particle radiation therapy system.
	892.5300	Medical neutron radiation therapy system.
	892.5650	Manual radionuclide applicator system.
	892.5700	Remote controlled radionuclide applicator system.
	892.5710	Radiation therapy beam-shaping block.
	892.5730	Radionuclide brachytherapy source.
	892.5740	Radionuclide teletherapy source.
	892.5750	Radionuclide radiation therapy system.
	892.5770	Powered radiation therapy patient support assembly.
	892.5780	Light beam patient position indicator.
	892.5840	Radiation therapy simulation system.
	892.5900	X-ray radiation therapy system.
	892.5930	Therapeutic x-ray tube housing assembly.
	892.6500	Personnel protective shield.