StrokeSENS ASPECTS Software Application is an AI-enabled medical device from Circle Cardiovascular Imaging Inc., listed by FDA (510(k), K250221) with a decision date of 2025-07-01. Review panel: Radiology.
| FDA submission number | K250221 |
|---|---|
| Pathway | 510(k) |
| Company | Circle Cardiovascular Imaging Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2025-07-01 |
| Decision | Substantially Equivalent |
| Product code | POK |
| Classification | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer |
| Device class | 2 |
| Regulation number | 892.2060 |
| Review time (calendar days) | 158 |
| Applicant country | CA |
Official FDA database record · FDA AI-enabled device list
More devices from Circle Cardiovascular Imaging Inc. · All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.