# K171719: Hybrid3D

- Pathway: 510(k) (Traditional)
- Applicant: Hermes Medical Solutions AB
- Decided: Nov 21, 2017 after 165 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K010641 (2001). 28 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 34 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.
- K163394: Hybrid3D, Hermes Medical Solutions AB (2017) Summary page 4.

## Most influential descendants
- K181468: Hybrid3D (2018), 4 descendants of its own
- K202882: Affinity (2020), 1 descendant of its own
- K253835: Affinity (2026), 0 descendants of its own
- K202392: SIR-Spheres Microspheres Activity Calculator (SMAC) (2020), 0 descendants of its own
- K193152: Affinity (2020), 0 descendants of its own

## Indications for use
Hybrid3D 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/K171719
Methodology: https://510kreport.com/methodology