§ 892.1730. Photofluorographic x-ray system.
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/us/cfr/t21/s§ 892.1730·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]