CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 892—RADIOLOGY DEVICES > SUBPART B—Diagnostic Devices (§892.1000 to §892.2050) > 892.1600—Angiographic x-ray system.

892.1600—Angiographic x-ray system.

(a) Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
(b) Classification. Class II.