X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
FDA product code QHA · Class II (moderate risk) · 21 CFR 892.1600 · Radiology
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.
7510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251355 | X1-FFRQHA · Traditional | Spectrawave, Inc. | 10/17/2025SE |
| K243769 | QFR (3.0)QHA · Traditional | Qfr Solutions BV | 04/04/2025SE |
| K232147 | CAAS WorkstationQHA · Traditional | Pie Medical Imaging BV | 04/09/2024SE |
| K230303 | AccuFFRangio PlusQHA · Special | ArteryFlow Technology Co., Ltd. | 03/02/2023SE |
| K221711 | AccuICASQHA · Traditional | ArteryFlow Technology Co., Ltd. | 02/28/2023SE |
| K210093 | AccuFFRangioQHA · Traditional | ArteryFlow Technology Co., Ltd. | 09/10/2021SE |
| K182611 | Qangio XA 3DQHA · Traditional | Medis Medical Imaging Systems BV | 05/30/2019SE |