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Electronic Code of Federal Regulations

e-CFR data is current as of March 26, 2020

Title 21Chapter ISubchapter HPart 892Subpart B → §892.1600


Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart B—Diagnostic Devices


§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.

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