21 C.F.R. § 892.1100 Scintillation (gamma) camera.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart B—Diagnostic Devices
§ 892.1100 Scintillation (gamma) camera.
