The following data is part of a premarket notification filed by Olea Medical with the FDA for Breastscape V1.0.
| Device ID | K211431 |
| 510k Number | K211431 |
| Device Name: | Breastscape V1.0 |
| Classification | Automated Radiological Image Processing Software |
| Applicant | Olea Medical 93 Avenue Des Sorbiers, ZI ATHELIA IV La Ciotat, FR 13600 |
| Contact | Nathalie Palumbo |
| Correspondent | John J. Smith Hogan Lovells US LLP 555 Thirteenth Street NW Washington, DC 20004 |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-07 |
| Decision Date | 2021-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EOLEBREASTSCAPEV1P00 | K211431 | 000 |