Title 21: Food and Drugs
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/ PART 892 - RADIOLOGY DEVICES
/ Subpart B - Diagnostic Devices / § 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).