21 C.F.R. § 892.1100

Current through October 31, 2024
Section 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).

21 C.F.R. §892.1100

55 FR 48443, Nov. 20, 1990, as amended at 66 FR 46953 , Sept. 10, 2001