21 CFR § 892.1600
Angiographic x-ray system
June 25, 2020
(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.