Data / Medical devices / Automated Radiological Image Processing Software / France
FDA-registered makers of Automated Radiological Image Processing Software in France: 14 establishments
14 establishments in France are registered with the FDA to make Automated Radiological Image Processing Software (product code QIH). 9 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Automated Radiological Image Processing Software
- Product code
- QIH
- Country
- France
Makers of Automated Radiological Image Processing Software in France
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| EOS imaging | Paris, France | Manufacturer | 3 | November 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Medicrea International | RILLIEUX-LA-PAPE Auvergne-Rhone-Alpes, France | Specification developer | 2 | May 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| Therapixel | Nice Alpes-Maritimes, France | Complaint file establishment, Manufacturer | 2 | August 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Avatar Medical | paris Ile-de-France, France | Manufacturer | 1 | October 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Brightheart SAS | Paris, France | Manufacturer | 1 | June 5, 2025 | 0 | 0 | 0 | api.fda.gov |
| Gleamer | Paris Ile-de-France, France | Manufacturer | 1 | February 5, 2025 | 0 | 0 | 0 | api.fda.gov |
| Inheart | Pessac Gironde, France | Manufacturer | 1 | February 29, 2024 | 0 | 0 | 0 | api.fda.gov |
| Olea Medical | La Ciotat Bouches-du-Rhone, France | Manufacturer | 1 | August 2, 2021 | 0 | 0 | 0 | api.fda.gov |
| Rebrain | PESSAC Gironde, France | Manufacturer | 1 | August 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Caranx Medical | Nice Provence-Alpes-Cote d'Azur, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnoly | Lyon 3e Arrondissement Rhone, France | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems SCS | Buc, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Parallel Design SAS | Valbonne, France | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sonio | Paris, France | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.