(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]