§892.1670. Spot-film device.
21 C.F.R. § 892.1670
Identification. A spot-film device is an electromechanical component of a fluoroscopic x-ray system that is intended to be used for medical purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy.
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.
Notes, amendments, and revision history
Amendments
[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 53 FR 1567, Jan. 20, 1988, unless otherwise noted.
Amendments
[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]