Code of Federal Regulations · Section
§ 892.1660 — Non-image-intensified Fluoroscopic X-ray System
21 C.F.R. § 892.1660
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(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.
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351