Current through October 31, 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 .48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819 , Dec. 30, 2019