# K121459: Syngo.MR Neurology

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 22, 2012 after 36 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: 9 generations back to K971684 (1997). 32 ancestors in all.
3 later devices descend from it; 1 cites it directly.
2 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111242: Magnetom Aera and Magnetom Skyra, Siemens Medical Solutions USA, Inc. (2011) Summary page 3.
- K092519: Syngo.X, Siemens AG Medical Solutions (2009) Summary page 3.

## Most influential descendants
- K131447: Intuition - Tda, Tva, Parametric Mapping (2013), 2 descendants of its own
- K200750: Neuro.Al Algorithm (2020), 1 descendant of its own
- K220349: TeraRecon Neuro (2022), 0 descendants of its own

## Indications for use
syngo.MR Neurology is a software solution to be used for viewing and evaluation of Neuroperfusion MR images for the routine use in MR image viewing. It is a syngo.via based software option with dedicated MR specific workflows and basic MR specific evaluation tools and thus supports interpretation and evaluation of examinations within healthcare institutions, for example in Radiology, Neuroradiology and Neurosurgery environments.

Source page: https://510kreport.com/device/K121459
Methodology: https://510kreport.com/methodology