# Hermes Medical Solutions AB

- Location (FDA's records): Stockholm, SE
- FDA decisions: 17 (2012–2026): 17 510(k) clearances
- Product codes: KPS (13), QIH (2), LLZ (1), IYX (1)
- 510(k) review time since 2016: median 167 days, against 88 for FDA's reviews in the same codes and years (1 of 12 faster)
- Predicates its devices cite: 32 (19 its own); citations of its devices by later devices: 28 (19 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nuclear Diagnostics, Inc.: 5 (https://510kreport.com/company/nuclear-diagnostics)
- Ge Medical Systems F.I. Haifa: 4 (https://510kreport.com/company/ge-medical-systems-fi-haifa)
- Mim Software, Inc.: 1 (https://510kreport.com/company/mim-software)
- GE Medical Systems: 1 (https://510kreport.com/company/ge-medical-systems)
- Vanderbilt University: 1 (https://510kreport.com/company/vanderbilt-university)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)

## Firms that cite its devices most
- Voximetry, Incorporated: 2 (https://510kreport.com/company/voximetry)
- Versant Medical Physics and Radiation Safety: 1 (https://510kreport.com/company/versant-medical-physics-and-radiation-safety)
- Keosys Sas: 1 (https://510kreport.com/company/keosys)
- Mim Software, Inc.: 1 (https://510kreport.com/company/mim-software)
- Sirtex Medical US Holdings, Inc.: 1 (https://510kreport.com/company/sirtex-medical-us-holdings)
- Radiopharmaceutical Imaging and Dosimetry, LLC: 1 (https://510kreport.com/company/radiopharmaceutical-imaging-and-dosimetry)
- Syntermed, Inc.: 1 (https://510kreport.com/company/syntermed)
- Radiopharmaceutical Imaging & Dosimetry, LLC: 1 (https://510kreport.com/company/radiopharmaceutical-imaging-dosimetry)

## Its most-cited devices
- K163687: Olinda Exm (2017), cited by 5
- K131233: Hermes Medical Imaging Suite V5.3 (2013), cited by 3
- K181468: Hybrid3D (2018), cited by 3
- K153056: Hermes Medical Imaging Suite v5.6 (2016), cited by 3
- K121278: Hermes Medical Imaging Suite V5.2 (2012), cited by 2
- K191216: Voxel Dosimetry™ v1.0 (2019), cited by 2

## Recent decisions
- 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)

Source page: https://510kreport.com/company/hermes-medical-solutions