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 AZmed with 6 510(k) clearances and 5 AI-enabled devices. The most recent is a 510(k) clearance dated Aug 28, 2026: Rayvolve AZchest.
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 |
|---|---|---|
| Aug 28, 2026 | Rayvolve AZchestK261378 · QBS | 510(k) clearances |
| May 12, 2026 | RayvolveK260378 · QBS | 510(k) clearances |
| May 12, 2026 | RayvolveK260378 · Radiology | AI-enabled devices |
| Mar 26, 2025 | Rayvolve LNK243831 · MYN | 510(k) clearances |
| Mar 26, 2025 | Rayvolve LNK243831 · Radiology | AI-enabled devices |
| Mar 21, 2025 | Rayvolve PTX-PEK243808 · QFM | 510(k) clearances |
| Mar 21, 2025 | Rayvolve PTX-PEK243808 · Radiology | AI-enabled devices |
| Jul 17, 2024 | RayvolveK240845 · QBS | 510(k) clearances |
| Jul 17, 2024 | RayvolveK240845 · Radiology | AI-enabled devices |
| Jun 2, 2022 | RayvolveK220164 · QBS | 510(k) clearances |
| Jun 2, 2022 | RayvolveK220164 · 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
