21 C.F.R. § 892.1850
Radiographic film cassette.
Cite as 21 C.F.R. § 892.1850 (2026)
(a)
Identification.
A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.
(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019]
- Cross-references to the CFR
- 892.9.