CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 892—RADIOLOGY DEVICES > SUBPART F—Therapeutic Devices (§892.5050 to §892.5930) > 892.5730—Radionuclide brachytherapy source.

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.