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) > 892.5740—Radionuclide teletherapy source.

892.5740—Radionuclide teletherapy source.

(a) Identification. A radionuclide teletherapy source is a device consisting of a radionuclide enclosed in a sealed container. The device is intended for radiation therapy, with the radiation source located at a distance from the patient's body.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9.

Code of Federal Regulations

[53 FR 1567, Jan. 20, 1988, as amended at 59 FR 63015, Dec. 7, 1994; 66 FR 38819, July 25, 2001]