21 CFR Subpart B
Diagnostic Devices
June 25, 2020
§
892.1220
Fluorescent scanner
§
892.1390
Radionuclide rebreathing system
§
892.1180
Bone sonometer
§
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
§
892.1300
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
§
892.1400
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
§
892.2060
Radiological computer-assisted diagnostic software for lesions suspicious of cancer
§
892.2070
Medical image analyzer
§
892.2080
Radiological computer aided triage and notification software
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