Data / Medical devices / France / Rebrain
Rebrain: FDA-registered device maker in PESSAC Gironde, France, 1 510(k) clearance
Rebrain is registered with the FDA (registration 3030088963) in PESSAC Gironde, France. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 12, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030088963
- Address
- PTIB, Hopital Xavier Arnozan, Avenue du Haut Leveque, PESSAC Gironde, France, 33600
- Owner or operator
- REBRAIN (10089358)
- Roles
- Manufacturer
- First device listed
- October 21, 2024
- Registered through
- 2026
- Brand names listed
- OptimMRI
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 12, 2024 | K242054 | OptimMRI (v2) | QIH | Substantially Equivalent | Rebrain, Sas | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Automated Radiological Image Processing Software
Updated August 12, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.