# K182904: syngo.MR Applications

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 5, 2019 after 262 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: 15 generations back to K971684 (1997). 191 ancestors in all.
14 later devices descend from it; 3 cite it directly.
5 of 206 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180336: syngo.MR Applications, Siemens Medical Solutions USA, Inc. (2018) Summary page 5.

## Most influential descendants
- K193290: AI-Rad Companion Brain MR (2020), 11 descendants of its own
- K220497: CoLumbo (2022), 6 descendants of its own
- K213706: AI-Rad Companion Brain MR (2022), 3 descendants of its own
- K241211: CoLumbo (2024), 2 descendants of its own
- K232305: AI-Rad Companion Brain MR (2023), 1 descendant of its own

## 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/K182904
Methodology: https://510kreport.com/methodology