# Gleamer

- Location (FDA's records): Paris, FR
- FDA decisions: 5 (2022–2026): 5 510(k) clearances
- Names in FDA's records: Gleamer (3); Gleamer Sas (2)
- Product codes: QBS (2), MYN (2), QIH (1)
- 510(k) review time since 2016: median 267 days, against 150 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 4 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Imagen Technologies, Inc.: 2 (https://510kreport.com/company/imagen-technologies)
- Ib Lab GmbH: 1 (https://510kreport.com/company/ib-lab)

## Firms that cite its devices most
- Milvue: 1 (https://510kreport.com/company/milvue)
- GE Medical Systems: 1 (https://510kreport.com/company/ge-medical-systems)

## Its most-cited devices
- K212365: BoneView (2022), cited by 2
- K222176: BoneView (2023), cited by 1
- K241620: ChestView US (2025), cited by 1

## Recent decisions
- K252486: ChestView US (1.1) (Sep 9, 2026)
- K241620: ChestView US (Feb 27, 2025)
- K241593: BoneMetrics (US) (Feb 5, 2025)
- K222176: BoneView (Mar 2, 2023)
- K212365: BoneView (Mar 1, 2022)

Source page: https://510kreport.com/company/gleamer