21 C.F.R. § 892.1650 Image-intensified fluoroscopic x-ray system.
Title 21 - Food and Drugs
(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 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 §892.9. [53 FR 1567, Jan. 20, 1988, as amended at 66 FR 57369, Nov. 15, 2001]
Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart B—Diagnostic Devices
§ 892.1650 Image-intensified fluoroscopic x-ray system.
