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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
 
PART 892RADIOLOGY DEVICES
 

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).

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.

Subparts C-E [Reserved]

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.
   § 892.5730 - 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.

Subpart G--Miscellaneous Devices
   § 892.6500 - Personnel protective shield.

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

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