QHA

7 FDA 510(k) clearances · Product code

FDA profile

Official device name

X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

Device class

Class II (moderate risk)

Regulation

21 CFR 892.1600

Medical specialty

Radiology

FDA definition

X-ray angiographic imaging based coronary vascular simulation software device is a prescription device that provides an image analysis tool to assess blood flow in the coronary vascular system using X-ray angiographic imaging data. X-ray angiographic imaging based coronary vascular simulation software device solves algorithms and yields simulation-based metrics for certain cardiology applications. X-ray angiographic imaging based coronary vascular simulation software device cannot be used alone for clinical decision making and clinical management, and is a tool intended to generate results for use and review by a qualified clinician.

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