Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwedenLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Hermes Medical Solutions with 17 510(k) clearances, 1 device recall and 1 AI-enabled device. The most recent is a 510(k) clearance dated Jul 31, 2026: Affinity.
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.
| Jul 31, 2026 | AffinityK253835 · QIH | 510(k) clearances |
| Sep 9, 2025 | Hybrid Viewer (00859873006240)K252477 · KPS | 510(k) clearances |
| Jul 30, 2025 | Voxel Dosimetry (00859873006226)K243919 · QIH | 510(k) clearances |
| Jul 30, 2025 | Voxel Dosimetry (00859873006226)K243919 · Radiology | AI-enabled devices |
| Nov 8, 2024 | Hybrid Viewer (00859873006189)K241364 · KPS | 510(k) clearances |
| Oct 31, 2024 | Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0Class II · Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT stu | Device recalls |
| Dec 23, 2020 | AffinityK202882 · KPS | 510(k) clearances |
| Feb 14, 2020 | AffinityK193152 · KPS | 510(k) clearances |
| Oct 17, 2019 | Voxel Dosimetry™ v1.0K191216 · LLZ | 510(k) clearances |
| Oct 25, 2018 | Hybrid3DK181468 · KPS | 510(k) clearances |
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
