892.1110 Positron camera.§ 892.1110 Positron camera.
(a) Identification. A positron camera is a device intended to image the distribution of positron-emitting radionuclides in the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
(b) Classification. Class I (general controls).[55 FR 48444, Nov. 20, 1990, as amended at 66 FR 46953, Sept. 10, 2001]