Regulation Text
(a) Identification. A fluorescent scanner is a device intended to measure the induced fluorescent radiation in the body by exposing the body to certain x-rays or low-energy gamma rays. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts and accessories.
(b) Classification. Class II.
Authority
21 U.S.C. 351,360,360c,360e,360j,360l,371.