# K253835: Affinity

- Pathway: 510(k) (Traditional)
- Applicant: Hermes Medical Solutions AB
- Decided: Jul 31, 2026 after 242 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K010641 (2001). 111 ancestors in all.
No later device cites it as a predicate yet.
1 of 112 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243919: Voxel Dosimetry (00859873006226), Hermes Medical Solutions AB (2025) Summary page 5.
- K202882: Affinity, Hermes Medical Solutions AB (2020) Summary page 5.

## Indications for use
Affinity displays, processes and analyzes nuclear medicine and radiology imaging data for investigation of physiological or pathological states. The functionality in Affinity is not intended to replace visual assessment by the intended user. The information obtained from the images, including quantitative analysis, may be used, in conjunction with other patient-related data, to inform clinical management.

Source page: https://510kreport.com/device/K253835
Methodology: https://510kreport.com/methodology