Data / Medical devices / France / Gleamer
Gleamer: FDA-registered device maker in Paris Ile-de-France, France, 5 510(k) clearances
Gleamer is registered with the FDA (registration 3021907554) in Paris Ile-de-France, France. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 9, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021907554
- Address
- 47bis Rue des Vinaigriers, Paris Ile-de-France, France, 75010
- Owner or operator
- GLEAMER (10084623)
- Roles
- Manufacturer
- First device listed
- March 14, 2022
- Registered through
- 2026
- Brand names listed
- BoneMetrics US, BoneView, ChestView US
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Medical Image | MYN | 2 | Manufacturer | accessdata.fda.gov |
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Radiological Computer Assisted Detection/Diagnosis Software For Fracture | QBS | 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 |
|---|---|---|---|---|---|---|
| September 9, 2026 | K252486 | ChestView US (1.1) | MYN | Substantially Equivalent | Gleamer | accessdata.fda.gov |
| February 27, 2025 | K241620 | ChestView US | MYN | Substantially Equivalent | Gleamer Sas | accessdata.fda.gov |
| February 5, 2025 | K241593 | BoneMetrics (US) | QIH | Substantially Equivalent | Gleamer Sas | accessdata.fda.gov |
| March 2, 2023 | K222176 | BoneView | QBS | Substantially Equivalent | Gleamer | accessdata.fda.gov |
| March 1, 2022 | K212365 | BoneView | QBS | Substantially Equivalent | Gleamer | accessdata.fda.gov |
Compare with other makers
- All makers of Radiological Computer Assisted Detection/Diagnosis Software For Fracture
- All makers of Analyzer, Medical Image
- All makers of Automated Radiological Image Processing Software
Updated September 9, 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.