Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Gleamer with 5 510(k) clearances and 4 AI-enabled devices. The most recent is a 510(k) clearance dated Sep 9, 2026: ChestView US (1.1).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Sep 9, 2026 | ChestView US (1.1)K252486 · MYN | 510(k) clearances |
| Feb 27, 2025 | ChestView USK241620 · MYN | 510(k) clearances |
| Feb 27, 2025 | ChestView USK241620 · Radiology | AI-enabled devices |
| Feb 5, 2025 | BoneMetrics (US)K241593 · QIH | 510(k) clearances |
| Feb 5, 2025 | BoneMetrics (US)K241593 · Radiology | AI-enabled devices |
| Mar 2, 2023 | BoneViewK222176 · QBS | 510(k) clearances |
| Mar 2, 2023 | BoneViewK222176 · Radiology | AI-enabled devices |
| Mar 1, 2022 | BoneViewK212365 · QBS | 510(k) clearances |
| Mar 1, 2022 | BoneViewK212365 · Radiology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
