# K193152: Affinity

- Pathway: 510(k) (Traditional)
- Applicant: Hermes Medical Solutions AB
- Decided: Feb 14, 2020 after 93 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: 15 generations back to K010641 (2001). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181468: Hybrid3D, Hermes Medical Solutions AB (2018) Summary page 4.

## Indications for use
AFFINITY is a software application used to process, display, analyse and manage nuclear medicine and other medical imaging data transferred from other workstations, PACS or acquisition stations. The information acquired from viewing the images is used, in conjunction with other patient related data, for diagnosis and monitoring of disease.

Source page: https://510kreport.com/device/K193152
Methodology: https://510kreport.com/methodology