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Title 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 892--RADIOLOGY DEVICES
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 | 892.1 | Scope. |
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| 892.3 | Effective dates of requirement for premarket approval. |
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| 892.9 | Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
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| 892.1000 | Magnetic resonance diagnostic device. |
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| 892.1100 | Scintillation (gamma) camera. |
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| 892.1110 | Positron camera. |
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| 892.1130 | Nuclear whole body counter. |
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| 892.1170 | Bone densitometer. |
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| 892.1200 | Emission computed tomography system. |
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| 892.1220 | Fluorescent scanner. |
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| 892.1300 | Nuclear rectilinear scanner. |
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| 892.1310 | Nuclear tomography system. |
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| 892.1320 | Nuclear uptake probe. |
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| 892.1330 | Nuclear whole body scanner. |
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| 892.1350 | Nuclear scanning bed. |
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| 892.1360 | Radionuclide dose calibrator. |
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| 892.1370 | Nuclear anthropomorphic phantom. |
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| 892.1380 | Nuclear flood source phantom. |
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| 892.1390 | Radionuclide rebreathing system. |
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| 892.1400 | Nuclear sealed calibration source. |
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| 892.1410 | Nuclear electrocardiograph synchronizer. |
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| 892.1420 | Radionuclide test pattern phantom. |
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| 892.1540 | Nonfetal ultrasonic monitor. |
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| 892.1550 | Ultrasonic pulsed doppler imaging system. |
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| 892.1560 | Ultrasonic pulsed echo imaging system. |
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| 892.1570 | Diagnostic ultrasonic transducer. |
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| 892.1600 | Angiographic x-ray system. |
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| 892.1610 | Diagnostic x-ray beam-limiting device. |
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| 892.1620 | Cine or spot fluorographic x-ray camera. |
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| 892.1630 | Electrostatic x-ray imaging system. |
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| 892.1640 | Radiographic film marking system. |
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| 892.1650 | Image-intensified fluoroscopic x-ray system. |
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| 892.1660 | Non-image-intensified fluoroscopic x-ray system. |
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| 892.1670 | Spot-film device. |
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| 892.1680 | Stationary x-ray system. |
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| 892.1700 | Diagnostic x-ray high voltage generator. |
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| 892.1710 | Mammographic x-ray system. |
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| 892.1720 | Mobile x-ray system. |
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| 892.1730 | Photofluorographic x-ray system. |
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| 892.1740 | Tomographic x-ray system. |
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| 892.1750 | Computed tomography x-ray system. |
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| 892.1760 | Diagnostic x-ray tube housing assembly. |
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| 892.1770 | Diagnostic x-ray tube mount. |
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| 892.1820 | Pneumoencephalographic chair. |
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| 892.1830 | Radiologic patient cradle. |
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| 892.1840 | Radiographic film. |
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| 892.1850 | Radiographic film cassette. |
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| 892.1860 | Radiographic film/cassette changer. |
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| 892.1870 | Radiographic film/cassette changer programmer. |
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| 892.1880 | Wall-mounted radiographic cassette holder. |
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| 892.1890 | Radiographic film illuminator. |
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| 892.1900 | Automatic radiographic film processor. |
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| 892.1910 | Radiographic grid. |
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| 892.1920 | Radiographic head holder. |
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| 892.1940 | Radiologic quality assurance instrument. |
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| 892.1950 | Radiographic anthropomorphic phantom. |
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| 892.1960 | Radiographic intensifying screen. |
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| 892.1970 | Radiographic ECG/respirator synchronizer. |
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| 892.1980 | Radiologic table. |
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| 892.1990 | Transilluminator for breast evaluation. |
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| 892.2010 | Medical image storage device. |
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| 892.2020 | Medical image communications device. |
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| 892.2030 | Medical image digitizer. |
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| 892.2040 | Medical image hardcopy device. |
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| 892.2050 | Picture archiving and communications system. |
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| 892.5050 | Medical charged-particle radiation therapy system. |
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| 892.5300 | Medical neutron radiation therapy system. |
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| 892.5650 | Manual radionuclide applicator system. |
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| 892.5700 | Remote controlled radionuclide applicator system. |
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| 892.5710 | Radiation therapy beam-shaping block. |
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| 892.5730 | Radionuclide brachytherapy source. |
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| 892.5740 | Radionuclide teletherapy source. |
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| 892.5750 | Radionuclide radiation therapy system. |
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| 892.5770 | Powered radiation therapy patient support assembly. |
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| 892.5780 | Light beam patient position indicator. |
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| 892.5840 | Radiation therapy simulation system. |
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| 892.5900 | X-ray radiation therapy system. |
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| 892.5930 | Therapeutic x-ray tube housing assembly. |
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| 892.6500 | Personnel protective shield. |
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