CARA System is an AI-enabled medical device from Cara Medical, Ltd., listed by FDA (510(k), K252500) with a decision date of 2026-02-20. Review panel: Radiology.
| FDA submission number | K252500 |
|---|---|
| Pathway | 510(k) |
| Company | Cara Medical, Ltd. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2026-02-20 |
| Decision | Substantially Equivalent |
| Product code | OWB |
| Classification | Interventional Fluoroscopic X-Ray System |
| Device class | 2 |
| Regulation number | 892.1650 |
| Review time (calendar days) | 196 |
| Applicant country | VG |
Official FDA database record · FDA AI-enabled device list
All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.