X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
Regulation 892.1600
0510(k)s in 12 months (7 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QHA
| Company | 510(k)s | Recalls |
|---|---|---|
| ArteryFlow Technology Co., Ltd. | 3 | 0 |
| Medis Medical Imaging Systems BV | 1 | 0 |
| Pie Medical Imaging BV | 1 | 0 |
| Qfr Solutions BV | 1 | 0 |
| Spectrawave, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 17, 2025 | K251355 | X1-FFR Spectrawave, Inc. | QHA |
| Apr 4, 2025 | K243769 | QFR (3.0) Qfr Solutions BV, NL | QHA |
| Apr 9, 2024 | K232147 | CAAS Workstation Pie Medical Imaging BV, NL | QHA |
| Mar 2, 2023 | K230303 | AccuFFRangio Plus ArteryFlow Technology Co., Ltd., CN | QHA |
| Feb 28, 2023 | K221711 | AccuICAS ArteryFlow Technology Co., Ltd., CN | QHA |
| Sep 10, 2021 | K210093 | AccuFFRangio ArteryFlow Technology Co., Ltd., CN | QHA |
| May 30, 2019 | K182611 | Qangio XA 3D Medis Medical Imaging Systems BV, NL | QHA |
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