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X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

FDA product code QHA · 7 cleared devices

Class 2 Radiology
Regulation
21 CFR 892.1600
Review panel
RA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2019-05-30 – 2025-10-17

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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