§892.1100. Scintillation (gamma) camera.
21 C.F.R. § 892.1100
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.
Classification. Class I (general controls).
Notes, amendments, and revision history
Amendments
[55 FR 48443, Nov. 20, 1990, as amended at 66 FR 46953, Sept. 10, 2001]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 53 FR 1567, Jan. 20, 1988, unless otherwise noted.
Amendments
[55 FR 48443, Nov. 20, 1990, as amended at 66 FR 46953, Sept. 10, 2001]