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Code of Federal Regulations (Last Updated: July 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 |
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Subpart F - Therapeutic Devices |
§ 892.5730 - Radionuclide brachytherapy source.
Latest version.
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§ 892.5730 Radionuclide brachytherapy source.
(a) Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.
(b) Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019]