CFR /  Title 21  /  Part 892: Radiology Devices

Section No.	Description
Section 892.1	Effective dates of requirement for premarket approval
Section 892.3	Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
Section 892.9	Magnetic resonance diagnostic device
Section 892.1000	Scintillation (gamma) camera
Section 892.1100	Positron camera
Section 892.1110	Nuclear whole body counter
Section 892.1130	Bone densitometer
Section 892.1170	Bone sonometer
Section 892.1180	Emission computed tomography system
Section 892.1200	Fluorescent scanner
Section 892.1220	Nuclear rectilinear scanner
Section 892.1300	Nuclear tomography system
Section 892.1310	Nuclear uptake probe
Section 892.1320	Nuclear whole body scanner
Section 892.1330	Nuclear scanning bed
Section 892.1350	Radionuclide dose calibrator
Section 892.1360	Nuclear anthropomorphic phantom
Section 892.1370	Nuclear flood source phantom
Section 892.1380	Radionuclide rebreathing system
Section 892.1390	Nuclear sealed calibration source
Section 892.1400	Nuclear electrocardiograph synchronizer
Section 892.1410	Radionuclide test pattern phantom
Section 892.1420	Nonfetal ultrasonic monitor
Section 892.1540	Ultrasonic pulsed doppler imaging system
Section 892.1550	Ultrasonic pulsed echo imaging system
Section 892.1560	Diagnostic ultrasonic transducer
Section 892.1570	Angiographic x-ray system
Section 892.1600	Diagnostic x-ray beam-limiting device
Section 892.1610	Cine or spot fluorographic x-ray camera
Section 892.1620	Electrostatic x-ray imaging system
Section 892.1630	Radiographic film marking system
Section 892.1640	Image-intensified fluoroscopic x-ray system
Section 892.1650	Non-image-intensified fluoroscopic x-ray system
Section 892.1660	Spot-film device
Section 892.1670	Stationary x-ray system
Section 892.1680	Diagnostic x-ray high voltage generator
Section 892.1700	Mammographic x-ray system
Section 892.1710	Full-field digital mammography system
Section 892.1715	Mobile x-ray system
Section 892.1720	Photofluorographic x-ray system
Section 892.1730	Tomographic x-ray system
Section 892.1740	Computed tomography x-ray system
Section 892.1750	Diagnostic x-ray tube housing assembly
Section 892.1760	Diagnostic x-ray tube mount
Section 892.1770	Pneumoencephalographic chair
Section 892.1820	Radiologic patient cradle
Section 892.1830	Radiographic film
Section 892.1840	Radiographic film cassette
Section 892.1850	Radiographic film/cassette changer
Section 892.1860	Radiographic film/cassette changer programmer
Section 892.1870	Wall-mounted radiographic cassette holder
Section 892.1880	Radiographic film illuminator
Section 892.1890	Automatic radiographic film processor
Section 892.1900	Radiographic grid
Section 892.1910	Radiographic head holder
Section 892.1920	Radiologic quality assurance instrument
Section 892.1940	Radiographic anthropomorphic phantom
Section 892.1950	Radiographic intensifying screen
Section 892.1960	Radiographic ECG/respirator synchronizer
Section 892.1970	Radiologic table
Section 892.1980	Transilluminator for breast evaluation
Section 892.1990	Medical image storage device
Section 892.2010	Medical image communications device
Section 892.2020	Medical image digitizer
Section 892.2030	Medical image hardcopy device
Section 892.2040	Picture archiving and communications system
Section 892.2050	Medical charged-particle radiation therapy system
Section 892.5050	Medical neutron radiation therapy system
Section 892.5300	Manual radionuclide applicator system
Section 892.5650	Remote controlled radionuclide applicator system
Section 892.5700	Radiation therapy beam-shaping block
Section 892.5710	Radionuclide brachytherapy source
Section 892.5730	Radionuclide teletherapy source
Section 892.5740	Radionuclide radiation therapy system
Section 892.5750	Powered radiation therapy patient support assembly
Section 892.5770	Light beam patient position indicator
Section 892.5780	Radiation therapy simulation system
Section 892.5840	X-ray radiation therapy system
Section 892.5900	Therapeutic x-ray tube housing assembly
Section 892.5930	Personnel protective shield
Section 892.6500	Scope