Code of Federal Regulations Title 21. Food and Drugs § 21.892.5700 Remote controlled radionuclide applicator system

(a) Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.

(b) Classification. Class II.