21 CFR § 892.1960 Radiology Devices

§ 892.1960 Radiographic intensifying screen.

Current through Sep 8, 2026 · Read all of Part 892

⚠ 3 pending changes to Part 892

(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]

← § 892.1950 Radiographic anthropomorphic phantom.§ 892.1970 Radiographic ECG/respirator synchronizer. →