# K090038: Syngo Brevis

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Apr 28, 2009 after 112 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K954678 (1996). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043216: Cadstream Version 4.0, Confirma, Inc. (2005) Summary page 3.
- K041286: Dynacad V1.0, Mri Devices Corp. (2004) Summary page 3.

## Indications for use
syngo BreVis is a software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. syngo BreVis supports evaluation of dynamic MR data. Depending on the region of interest, contrast agents may or may not be used. syngo 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 BreVis can also be used to provide measurements of the diameters, areas and volumes. Furthermore syngo 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 BreVis includes software to support the use of interventional coils and MR stereotactic localization devices to perform MR-guided interventional procedures (syngo BreVis Biopsy). Using information from MR images regarding the coordinates of a user-specified region of interest and fiducial coordinates, syngo BreVis provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion. syngo 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 BreVis must not be used for primary diagnostic interpretation. syngo BreVis also includes the option to add annotations based on the American College of Radiology's BI-RADS (Breast Imaging and Data System). When interpreted by a skilled physician, syngo BreVis provides information that may be useful in diagnosis. Patient management decisions should not be made based solely on the results of syngo BreVis analysis.

Source page: https://510kreport.com/device/K090038
Methodology: https://510kreport.com/methodology