21 C.F.R. § 892.1960 Radiographic intensifying screen.
Title 21 - Food and Drugs
(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. [53 FR 1567, Jan. 20, 1988, as amended at 65 FR 2323, Jan. 14, 2000]
Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart B—Diagnostic Devices
§ 892.1960 Radiographic intensifying screen.
