§892.1110. Positron camera.
21 C.F.R. § 892.1110
Identification. A positron camera is a device intended to image the distribution of positron-emitting radionuclides in the body. 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 48444, 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 48444, Nov. 20, 1990, as amended at 66 FR 46953, Sept. 10, 2001]