# K202882: Affinity

- Pathway: 510(k) (Traditional)
- Applicant: Hermes Medical Solutions AB
- Decided: Dec 23, 2020 after 86 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.
1 later device descends from it; 1 cites it directly.
0 of 32 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.

## Most influential descendants
- K253835: Affinity (2026), 0 descendants of its own

## 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. Warning! This application is not intended to replace visual assessment of tumors. The primary purpose of the application is to provide pre-selection of lesions for visual confirmation and to provide consistency and reproducibility when assessing tumor response to treatment

Source page: https://510kreport.com/device/K202882
Methodology: https://510kreport.com/methodology