Hermes Medical Solutions AB
FDA 510(k) & PMA Approved Devices — 13 products
Total Devices13
Categories4
Latest FDA decision2026-07-31
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K253835 | Affinity | QIH | 2026-07-31 | View |
| 510(k) | K252477 | Hybrid Viewer (00859873006240) | KPS | 2025-09-09 | View |
| 510(k) | K243919 | Voxel Dosimetry (00859873006226) | QIH | 2025-07-30 | View |
| 510(k) | K241364 | Hybrid Viewer (00859873006189) | KPS | 2024-11-08 | View |
| 510(k) | K202882 | Affinity | KPS | 2020-12-23 | View |
| 510(k) | K193152 | Affinity | KPS | 2020-02-14 | View |
| 510(k) | K191216 | Voxel Dosimetry™ v1.0 | LLZ | 2019-10-17 | View |
| 510(k) | K181468 | Hybrid3D | KPS | 2018-10-25 | View |
| 510(k) | K171719 | Hybrid3D | KPS | 2017-11-21 | View |
| 510(k) | K171681 | Hermes Medical Imaging Suite v5.7 | KPS | 2017-11-21 | View |
| 510(k) | K163687 | OLINDA EXM | IYX | 2017-07-19 | View |
| 510(k) | K163394 | Hybrid3D | KPS | 2017-05-22 | View |
| 510(k) | K153056 | Hermes Medical Imaging Suite v5.6 | KPS | 2016-06-01 | View |
No matching devices.