# K253495: syngo.MR Applications (VB80)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthineers AG
- Decided: Nov 20, 2025 after 23 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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 K971684 (1997). 192 ancestors in all.
No later device cites it as a predicate yet.
5 of 193 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192462: syngo.MR Applications, Siemens Medical Solutions USA, Inc. (2020) Summary page 5.

## Indications for use
syngo.MR Applications is a syngo based post-acquisition image processing software for viewing, manipulating, evaluating, and analyzing MR, MR-PET, CT, PET, CT-PET images and MR spectra.

Source page: https://510kreport.com/device/K253495
Methodology: https://510kreport.com/methodology