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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 892 - Radiology 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 - Medical image management and processing system. |
| § 892.2060 - Radiological computer-assisted diagnostic software for lesions suspicious of cancer. |
| § 892.2070 - xxx |
| § 892.2080 - Radiological computer aided triage and notification software. |
| Subparts C--E - XXX |
| 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. |
| Subpart G - Miscellaneous Devices |
| § 892.6500 - Personnel protective shield. |