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X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device is a medical device type in the Radiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
Radiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QHA

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Class 2

21 CFR 892.1600

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Radiology

Device Characteristics

No

No

No

Not Eligible

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.