# K171681: Hermes Medical Imaging Suite v5.7

- Pathway: 510(k) (Traditional)
- Applicant: Hermes Medical Solutions AB
- Decided: Nov 21, 2017 after 168 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K010641 (2001). 27 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153056: Hermes Medical Imaging Suite v5.6, Hermes Medical Solutions AB (2016) Summary page 4.
- K130884: Xeleris 3.1 Processing and Review Workstation, Ge Medical Systems F.I. Haifa (2013) Summary page 4.

## Most influential descendants
- K241364: Hybrid Viewer (00859873006189) (2024), 1 descendant of its own
- K252477: Hybrid Viewer (00859873006240) (2025), 0 descendants of its own

## Recalls of this device
- Oct 31, 2024 · Class II · Z-0678-2025: Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.

## Indications for use
HERMES Medical Imaging suite that provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

Source page: https://510kreport.com/device/K171681
Methodology: https://510kreport.com/methodology