Data / Medical devices / France / Avatar Medical
Avatar Medical: FDA-registered device maker in paris Ile-de-France, France, 3 510(k) clearances
Avatar Medical is registered with the FDA (registration 3027645731) in paris Ile-de-France, France. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 30, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027645731
- Address
- 11 Rue de lourmel, paris Ile-de-France, France, 75015
- Owner or operator
- AVATAR MEDICAL USA Inc (10088457)
- Roles
- Manufacturer
- First device listed
- July 26, 2023
- Registered through
- 2026
- Brand names listed
- Avatar Medical Software, Avatar Medical Vision, brAIn Shoulder Positioning
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 |
|---|---|---|---|---|---|---|
| March 30, 2026 | K253950 | Avatar Medical Vision | LLZ | Substantially Equivalent | Avatar Medical | accessdata.fda.gov |
| October 20, 2025 | K252665 | brAIn Shoulder Positioning | QIH | Substantially Equivalent | Avatar Medical | accessdata.fda.gov |
| May 24, 2023 | K222035 | Avatar Medical Software V1 | LLZ | Substantially Equivalent | Avatar Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Radiological Image Processing Software
- All makers of System, Image Processing, Radiological
Updated March 30, 2026. 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.