2 devices · 2 companies · 2025
Product code QHA: X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
2 devices under product code QHA, 2025, from 2 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device. 21 CFR 892.1600, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| X1-FFRK251355 · 510(k) | Spectrawave, Inc. | Radiology | database entry | |
| QFRK243769 · 510(k) | QFR Solutions bv | Radiology | database entry |
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