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Home Page > Executive Branch > Code of Federal Regulations > Electronic Code of Federal Regulations
e-CFR Data is current as of February 4, 2010
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 892--RADIOLOGY DEVICES
Subpart A--GENERAL PROVISIONS
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| Effective dates of requirement for premarket approval. |
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| Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
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Subpart B--DIAGNOSTIC DEVICES
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| Magnetic resonance diagnostic device. |
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| Scintillation (gamma) camera. |
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| Nuclear whole body counter. |
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| Emission computed tomography system. |
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| Nuclear rectilinear scanner. |
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| Nuclear tomography system. |
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| Nuclear whole body scanner. |
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| Radionuclide dose calibrator. |
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| Nuclear anthropomorphic phantom. |
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| Nuclear flood source phantom. |
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| Radionuclide rebreathing system. |
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| Nuclear sealed calibration source. |
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| Nuclear electrocardiograph synchronizer. |
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| Radionuclide test pattern phantom. |
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| Nonfetal ultrasonic monitor. |
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| Ultrasonic pulsed doppler imaging system. |
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| Ultrasonic pulsed echo imaging system. |
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| Diagnostic ultrasonic transducer. |
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| Angiographic x-ray system. |
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| Diagnostic x-ray beam-limiting device. |
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| Cine or spot fluorographic x-ray camera. |
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| Electrostatic x-ray imaging system. |
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| Radiographic film marking system. |
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| Image-intensified fluoroscopic x-ray system. |
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| Non-image-intensified fluoroscopic x-ray system. |
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| Diagnostic x-ray high voltage generator. |
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| Mammographic x-ray system. |
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| Photofluorographic x-ray system. |
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| Tomographic x-ray system. |
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| Computed tomography x-ray system. |
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| Diagnostic x-ray tube housing assembly. |
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| Diagnostic x-ray tube mount. |
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| Pneumoencephalographic chair. |
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| Radiologic patient cradle. |
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| Radiographic film cassette. |
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| Radiographic film/cassette changer. |
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| Radiographic film/cassette changer programmer. |
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| Wall-mounted radiographic cassette holder. |
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| Radiographic film illuminator. |
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| Automatic radiographic film processor. |
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| Radiographic head holder. |
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| Radiologic quality assurance instrument. |
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| Radiographic anthropomorphic phantom. |
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| Radiographic intensifying screen. |
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| Radiographic ECG/respirator synchronizer. |
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| Transilluminator for breast evaluation. |
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| Medical image storage device. |
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| Medical image communications device. |
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| Medical image hardcopy device. |
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| Picture archiving and communications system. |
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Subparts C-E--[RESERVED]
Subpart F--THERAPEUTIC DEVICES
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| Medical charged-particle radiation therapy system. |
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| Medical neutron radiation therapy system. |
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| Manual radionuclide applicator system. |
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| Remote controlled radionuclide applicator system. |
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| Radiation therapy beam-shaping block. |
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| Radionuclide brachytherapy source. |
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| Radionuclide teletherapy source. |
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| Radionuclide radiation therapy system. |
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| Powered radiation therapy patient support assembly. |
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| Light beam patient position indicator. |
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| Radiation therapy simulation system. |
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| X-ray radiation therapy system. |
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| Therapeutic x-ray tube housing assembly. |
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Subpart G--MISCELLANEOUS DEVICES
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| Personnel protective shield. |
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