(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.

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