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e-CFR data is current as of January 21, 2021

Title 21 → Chapter I → Subchapter H → Part 892

TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H—MEDICAL DEVICES

PART 892—RADIOLOGY DEVICES

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Subpart A—GENERAL PROVISIONS

§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).
rule

Subpart B—DIAGNOSTIC DEVICES

§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.
§892.1180
Bone sonometer.
§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.
§892.1715
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.
rule

Subparts C-E [Reserved]

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Subpart F—THERAPEUTIC DEVICES

§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.
§892.5720
Rectal balloon for prostate immobilization.
§892.5725
Absorbable perirectal spacer.
§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.
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Subpart G—MISCELLANEOUS DEVICES

§892.6500
Personnel protective shield.

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