The following data is part of a premarket notification filed by Olea Medical with the FDA for Olea Sphere V3.0.
| Device ID | K152602 |
| 510k Number | K152602 |
| Device Name: | Olea Sphere V3.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | OLEA MEDICAL 93 AVENUE DES SORBIERS, ZONE ATHELIA IV La Ciotat, FR 13600 |
| Contact | Caroline Lene |
| Correspondent | Caroline Lene OLEA MEDICAL 93 AVENUE DES SORBIERS, ZONE ATHELIA IV La Ciotat, FR 13600 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-11 |
| Decision Date | 2016-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EOLEOLEASPHEREV3P01 | K152602 | 000 |