# K253689: syngo Dynamics (VA41F)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare GmbH
- Decided: Apr 10, 2026 after 140 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: 13 generations back to K842308 (1984). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242551: syngo Dynamics (Version VA41D), Siemens Healthcare GmbH (2025) Summary page 5.

## Indications for use
syngo Dynamics is a multimodality, vendor agnostic Cardiology image and information system intended for medical image management and processing that provides capabilities relating to the review and digital processing of medical images. syngo Dynamics supports clinicians by providing post image processing functions for image manipulation, and/or quantification that are intended for use in the interpretation and analysis of medical images for disease detection, diagnosis, and/or patient management within healthcare institution’s network. syngo Dynamics is not intended to be used for display or diagnosis of digital mammography images in the U.S.

Source page: https://510kreport.com/device/K253689
Methodology: https://510kreport.com/methodology