21 C.F.R. § 892.1110

Current through October 31, 2024
Section 892.1110 - Positron camera
(a)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.
(b)Classification. Class I (general controls).

21 C.F.R. §892.1110

55 FR 48444, Nov. 20, 1990, as amended at 66 FR 46953 , Sept. 10, 2001