breastscape v1.0 is an AI-enabled medical device from Olea Medical, listed by FDA (510(k), K211431) with a decision date of 2021-08-02. Review panel: Radiology.
| FDA submission number | K211431 |
|---|---|
| Pathway | 510(k) |
| Company | Olea Medical |
| Review panel (specialty) | Radiology |
| FDA decision date | 2021-08-02 |
| Decision | Substantially Equivalent |
| Product code | QIH |
| Classification | Automated Radiological Image Processing Software |
| Device class | 2 |
| Regulation number | 892.2050 |
| Review time (calendar days) | 87 |
| Applicant country | FR |
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.