# K120315: Syngo.MR Spectro Engine, Syngo.MR Spectro SVS, Syngo.MR Spectro Csi, Syngo.MR Spectro Extension

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Apr 13, 2012 after 72 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: 8 generations back to K971684 (1997). 21 ancestors in all.
23 later devices descend from it; 2 cite it directly.
2 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101347: Magnetom Aera; Magnetom Skyra, Siemens Medical Solutions USA, Inc. (2010) Summary page 3.
- K092519: Syngo.X, Siemens AG Medical Solutions (2009) Summary page 3.

## 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
syngo.MR Spectroscopy is a post-processing application to analyze and evaluate MR spectroscopy data. It provides evaluation of MR Single Voxel Spectroscopy (SVS) data and MR Chemical Shift Imaging (CSI) data with workflow guidance to support the diagnostic process. syngo. MR Spectroscopy includes the possibility of an integrated reading of MR images and spectroscopy data for spectroscopy exams and focuses on ease-of-use by reducing complexity. A novel fit-algorithm reduces the need for manual data processing and offers the user reproducible evaluation results. When interpreted by a trained physician, these results provide information that may assist in diagnosis. The post-processing tool fits and displays spectra and provides intuitive representations of the metabolic profile. The calculation and display of predefined results such as spectra, spectral maps, and metabolite images is provided. The evaluation can be adapted by the customer via protocol modification and task configurations. Interactive reading of spectroscopy exams is supported by side-by-side display of MR images and spectroscopy results, and synchronized display.

Source page: https://510kreport.com/device/K120315
Methodology: https://510kreport.com/methodology