Brainomix 360 e-ASPECTS is an AI-enabled medical device from Brainomix Limited, listed by FDA (510(k), K221564) with a decision date of 2023-02-23. Review panel: Radiology.
| FDA submission number | K221564 |
|---|---|
| Pathway | 510(k) |
| Company | Brainomix Limited |
| Review panel (specialty) | Radiology |
| FDA decision date | 2023-02-23 |
| 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) | 268 |
| Applicant country | GB |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.