21 C.F.R. § 892.1960

Current through September 30, 2024
Section 892.1960 - Radiographic intensifying screen
(a)Identification. A radiographic intensifying screen is a device that is a thin radiolucent sheet coated with a luminescent material that transforms incident x-ray photons into visible light and intended for medical purposes to expose radiographic film.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9 .

21 C.F.R. §892.1960

53 FR 1567, Jan. 20, 1988, as amended at 65 FR 2323, Jan. 14, 2000