# K133401: Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR General

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 11, 2014 after 125 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: 11 generations back to K971684 (1997). 34 ancestors in all.
27 later devices descend from it; 3 cite it directly.
3 of 62 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 6.

## Most influential descendants
- K151353: syngo.MR Neurology, syngo.MR Oncology (2015), 25 descendants of its own
- 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

## 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 diagnostic 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. syngo.mMR General is a syngo based post-processing software for viewing, manipulating and evaluating MR, PET and MR-PET images. syngo.MR BreVis is a software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. syngo.MR BreVis supports evaluation of dynamic MR data. Depending on the region of interest, contrast agents may or may not be used. syngo.MR BreVis automatically registers serial patient motion to minimize the impact of patient motion and visualizes different enhancement characteristics in those areas that are within the scope of the indications for use of MRI FDA approved contrast agents (parametric image maps), Furthermore, it Performs other user-defined post-processing functions such as image subtractions, multiplanar reformats and maximum intensity projections. The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto the source image. syngo.MR BreVis can also be used to provide measurements of the diameters, areas and volumes. Furthermore syngo.MR BreVis can evaluate the uptake characteristics of segmented tissues that are within the scope of the indications for use of MRI FDA approved contrast agents. syngo.MR BreVis is optimized for viewing breast MR studies, and it also displays images from a number of other imaging modalities, like digitized mammographic images. The images by other imaging modalities displayed with syngo.MR BreVis must not be used for primary diagnostic interpretation. syngo.MR BreVis also includes the option to add annotations based on the American College of Radiology's BI-RADS (Breast Imaging Reporting and Data System). When interpreted by a skilled physician, syngo.MR BreVis provides information that may be useful in diagnosis. Patient management decisions should not be made based solely on the results of syngo.MR BreVis analysis.

Source page: https://510kreport.com/device/K133401
Methodology: https://510kreport.com/methodology