21 CFR §892.1220
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
- (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.