DEEPVESSEL FFR is an AI-enabled medical device from KeyaMed NA Inc., listed by FDA (510(k), K213657) with a decision date of 2022-04-01. Review panel: Cardiovascular.
| FDA submission number | K213657 |
|---|---|
| Pathway | 510(k) |
| Company | KeyaMed NA Inc. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2022-04-01 |
| Decision | Substantially Equivalent |
| Product code | PJA |
| Classification | Coronary Vascular Physiologic Simulation Software |
| Device class | 2 |
| Regulation number | 870.1415 |
| Review time (calendar days) | 133 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.