Company ยท FR
Gleamer
FDA 510(k) clearances and medical device recalls filed under this name, 2022 to 2026. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|
| MYN | Analyzer, Medical Image | 2 |
| QBS | Radiological Computer Assisted Detection/Diagnosis Software For Fracture | 2 |
| QIH | Automated Radiological Image Processing Software | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|
| Sep 9, 2026 | K252486 | ChestView US (1.1) Gleamer, FR | MYN |
| Feb 27, 2025 | K241620 | ChestView US Gleamer Sas, FR | MYN |
| Feb 5, 2025 | K241593 | BoneMetrics (US) Gleamer Sas, FR | QIH |
| Mar 2, 2023 | K222176 | BoneView Gleamer, FR | QBS |
| Mar 1, 2022 | K212365 | BoneView Gleamer, FR | QBS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|
| No recalls in this window. |