Code of Federal Regulations · Section
§ 892.1860 — Radiographic Film/cassette Changer
21 C.F.R. § 892.1860
View:
(a) Identification. A radiographic film/cassette changer is a device intended to be used during a radiologic procedure to move a radiographic film or cassette between x-ray exposures and to position it during the exposure.
(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.
Authorizing Statute
-
Adulterated drugs and devices21 U.S.C. § 351