§ 892.1650 - Image-intensified fluoroscopic x-ray system.

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a) Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II . When intended (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 66 FR 57369, Nov. 15, 2001; 84 FR 71818, Dec. 30, 2019]