FFRangio System is an AI-enabled medical device from CathWorks Ltd, listed by FDA (510(k), K182149) with a decision date of 2018-12-19. Review panel: Cardiovascular.
| FDA submission number | K182149 |
|---|---|
| Pathway | 510(k) |
| Company | CathWorks Ltd |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2018-12-19 |
| Decision | Substantially Equivalent |
| Product code | QEK |
| Classification | Angiographic Coronary Vascular Physiologic Simulation Software |
| Device class | 2 |
| Regulation number | 870.1415 |
| Review time (calendar days) | 133 |
| Applicant country | IL |
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.