Coronary Vascular Physiologic Simulation Software
FDA product code PJA · Class II (moderate risk) · 21 CFR 870.1415 · Cardiovascular
A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.
8510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250902 | HeartFlow AnalysisPJA · Traditional | HeartFlow, Inc. | 07/18/2025SE |
| K213857 | HeartFlow AnalysisPJA · Traditional | HeartFlow, Inc. | 10/14/2022SE |
| K213657 | Deepvessel FFRPJA · Traditional | Keyamed Na, Inc. | 04/01/2022SE |
| K203329 | HeartFlow AnalysisPJA · Traditional | HeartFlow, Inc. | 01/08/2021SE |
| K190925 | HeartFlow FFRct AnalysisPJA · Traditional | HeartFlow, Inc. | 08/15/2019SE |
| K182035 | FFRctPJA · Special | HeartFlow, Inc. | 12/06/2018SE |
| K161772 | FFRctPJA · Traditional | HeartFlow, Inc. | 08/24/2016SE |
| K152733 | FFRctPJA · Traditional | HeartFlow, Inc. | 01/13/2016SE |