Data / Medical devices / France / Milvue
Milvue: FDA-registered device maker in Paris Ile-de-France, France, 2 510(k) clearances
Milvue is registered with the FDA (registration 3027453703) in Paris Ile-de-France, France. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 17, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027453703
- Address
- 35 rue Vaugelas, Paris Ile-de-France, France, 75015
- Owner or operator
- Milvue (10092068)
- Roles
- Manufacturer
- First device listed
- December 1, 2024
- Registered through
- 2026
- Brand names listed
- SmartChest, TechCare Trauma
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Radiological Computer Assisted Detection/Diagnosis Software For Fracture | QBS | 2 | Manufacturer | accessdata.fda.gov |
| Radiological Computer-Assisted Prioritization Software For Lesions | QFM | 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 |
|---|---|---|---|---|---|---|
| January 17, 2025 | K242171 | TechCare Trauma | QBS | Substantially Equivalent | Milvue | accessdata.fda.gov |
| May 10, 2024 | K232410 | SmartChest | QFM | Substantially Equivalent | Milvue | accessdata.fda.gov |
Compare with other makers
- All makers of Radiological Computer Assisted Detection/Diagnosis Software For Fracture
- All makers of Radiological Computer-Assisted Prioritization Software For Lesions
Updated January 17, 2025. 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.