HeartFlow Analysis is an AI-enabled medical device from HeartFlow, Inc., listed by FDA (510(k), K250902) with a decision date of 2025-07-18. Review panel: Cardiovascular.
| FDA submission number | K250902 |
|---|---|
| Pathway | 510(k) |
| Company | HeartFlow, Inc. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2025-07-18 |
| Decision | Substantially Equivalent |
| Product code | PJA |
| Classification | Coronary Vascular Physiologic Simulation Software |
| Device class | 2 |
| Regulation number | 870.1415 |
| Review time (calendar days) | 114 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
More devices from HeartFlow, Inc. · All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.