510(k) · Cleared
ClearedSyngo Brevis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Apr 28, 2009 as substantially equivalent to K043216 (Confirma, Inc., 2005) and 1 other predicate after a 112-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Apr 28, 2009
- Review
- 112 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K954678 (1996). 31 ancestors in all, the oldest K913475 (1991). No later device cites it as a predicate yet.
- Root · 6 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 4 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 3 generations backK020546 Fusion 7DMirada Solutions, Ltd. · 2002
- 2 generations backK031779 CadstreamConfirma, Inc. · 2003
- 1 generation backK041286 Dynacad V1.0Mri Devices Corp. · 2004
- This deviceK090038 Syngo BrevisSiemens Medical Solutions USA, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −5 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −4 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −3 | K020546 | Fusion 7D | Mirada Solutions, Ltd. | 2002 | — |
| −2 | K031779 | Cadstream | Confirma, Inc. | 2003 | — |
| −1 | K041286 | Dynacad V1.0 | Mri Devices Corp. | 2004 | — |
| 0 (this device) | K090038 | Syngo Brevis | Siemens Medical Solutions USA, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043216 | Cadstream Version 4.0Summary page 3…the following cleared medical devices: Predicate Software FDA Clearance Number FDA Clearance Date Name CADstream V4.0 K043216 Jan 6, 2005 DynaCAD Vl.0 K041286 July 21, 2004 General Safety… | 2005 |
| * | K041286 | Dynacad V1.0Summary page 3…earance Number FDA Clearance Date Name CADstream V4.0 K043216 Jan 6, 2005 DynaCAD Vl.0 K041286 July 21, 2004 General Safety and Effectiveness Concerns: The introduction of syngo BreVis has no significant… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 7 of the 31 ancestors have a recall of any class.
- 8 other devices also cite its predicate K043216.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
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…
Read the full statement (322 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090038: Syngo Brevis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090038
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026