Hermes Medical Solutions AB
FDA Regulatory Profile
Hermes Medical Solutions AB appears in FDA public data with 1 recall, 17 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0678-2025, Class II) was initiated on Oct 31, 2024. Its most recent 510(k) clearance was granted on Jul 31, 2026.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 17
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0678-2025 | Class II | Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions af | Oct 31, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253835 | Affinity | Jul 31, 2026 |
| K252477 | Hybrid Viewer (00859873006240) | Sep 9, 2025 |
| K243919 | Voxel Dosimetry (00859873006226) | Jul 30, 2025 |
| K241364 | Hybrid Viewer (00859873006189) | Nov 8, 2024 |
| K202882 | Affinity | Dec 23, 2020 |
| K193152 | Affinity | Feb 14, 2020 |
| K191216 | Voxel Dosimetry v1.0 | Oct 17, 2019 |
| K181468 | Hybrid3D | Oct 25, 2018 |
| K171719 | Hybrid3D | Nov 21, 2017 |
| K171681 | Hermes Medical Imaging Suite v5.7 | Nov 21, 2017 |
| K163687 | OLINDA EXM | Jul 19, 2017 |
| K163394 | Hybrid3D | May 22, 2017 |
| K153056 | Hermes Medical Imaging Suite v5.6 | Jun 1, 2016 |
| K142631 | Hermes Medical Imaging Suite v5.5 | Dec 18, 2014 |
| K140269 | HERMES MEDICAL IMAGING SUITE V5.4 | May 8, 2014 |
| K131233 | HERMES MEDICAL IMAGING SUITE V5.3 | Jul 16, 2013 |
| K121278 | HERMES MEDICAL IMAGING SUITE V5.2 | Dec 18, 2012 |