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[A2]
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Electronic Code of Federal Regulations
| e-CFR data is current as of February 20, 2020
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
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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| Full-field digital mammography 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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| Radiological computer-assisted diagnostic software for lesions suspicious of cancer. |
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| Radiological computer aided triage and notification software. |
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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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| Rectal balloon for prostate immobilization. |
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| Absorbable perirectal spacer. |
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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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