892.1100 Scintillation (gamma) camera.§ 892.1100 Scintillation (gamma) camera.
(a) Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. 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 48443, Nov. 20, 1990, as amended at 66 FR 46953, Sept. 10, 2001]