# K151353: syngo.MR Neurology, syngo.MR Oncology

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 7, 2015 after 79 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: 12 generations back to K971684 (1997). 35 ancestors in all.
25 later devices descend from it; 3 cite it directly.
3 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133401: Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR General, Siemens Medical Solutions USA, Inc. (2014) Summary page 9.

## Most influential descendants
- K163294: syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology (2017), 23 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K151353
Methodology: https://510kreport.com/methodology