21 C.F.R. § 892.1110 Positron camera.
Title 21 - Food and Drugs
(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). [55 FR 48444, Nov. 20, 1990, as amended at 66 FR 46953, Sept. 10, 2001]
Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart B—Diagnostic Devices
§ 892.1110 Positron camera.
