21 C.F.R. § 892.1220
Fluorescent scanner.
Cite as 21 C.F.R. § 892.1220 (2026)
(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.