21 C.F.R. § 892.1840

Current through November 30, 2024
Section 892.1840 - Radiographic film
(a)Identification. Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides with a photographic emulsion intended to record images during diagnostic radiologic procedures.
(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 the limitations in § 892.9 .

21 C.F.R. §892.1840

53 FR 1567, Jan. 20, 1988, as amended at 66 FR 38819 , July 25, 2001