21 C.F.R. § 892.1730

Current through September 30, 2024
Section 892.1730 - Photofluorographic x-ray system
(a)Identification. A photofluorographic x-ray system is a device that includes a fluoroscopic x-ray unit and a camera intended to be used to produce, then photograph, a fluoroscopic image of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
(b)Classification. Class II (special controls). A discography kit intended for use with a photofluorographic x-ray system only 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. §892.1730

48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019