21 C.F.R. § 892.1660 Non-image-intensified fluoroscopic x-ray system.
Title 21 - Food and Drugs
(a) Identification. A non-image-intensified fluoroscopic x-ray system is a device intended to be used to visualize anatomical structures by using a fluorescent screen to convert a pattern of x-radiation into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. (b) Classification. Class II.
Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart B—Diagnostic Devices
§ 892.1660 Non-image-intensified fluoroscopic x-ray system.
