21 CFR 892.1600 — System, X-Ray, Angiographic

Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1600

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.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
IZISystem, X-Ray, Angiographic2197
QHAX-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device27SaMD
Innolitics

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