# K163294: syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 6, 2017 after 76 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: 13 generations back to K971684 (1997). 188 ancestors in all.
23 later devices descend from it; 2 cite it directly.
5 of 212 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130749: Syngo.MR General; Syngo.MR Cardiology; Syngo.MR Vascular, Siemens Medical Solutions USA, Inc. (2013) Summary page 9.
- K151353: syngo.MR Neurology, syngo.MR Oncology, Siemens Medical Solutions USA, Inc. (2015) Summary page 8.
- K153343: MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit, Siemens Medi Cal Solutions, Inc. (2016) Summary page 10.
- K150843: syngo®.via (version VB10A), Siemens AG (2015) Summary page 10.

## Most influential descendants
- K180336: syngo.MR Applications (2018), 21 descendants of its own
- K182904: syngo.MR Applications (2019), 14 descendants of its own
- 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

## Indications for use
The software comprising the syngo.MR post-processing applications is post-processing software/applications to be used for viewing and evaluating the designated images provided by a magnetic resonance diagnostic device. All of the software applications comprising the syngo.MR post-processing applications have their own indications for use. syngo.MR General is a syngo based post-processing software for viewing, manipulating and evaluating MR images. syngo.MR Cardiology is a syngo based post-processing software for viewing, manipulating and evaluating MR cardiac images. syngo.MR Neurology is a syngo based post-processing software for viewing, manipulating, and evaluating MR neurological images.

Source page: https://510kreport.com/device/K163294
Methodology: https://510kreport.com/methodology