510(k) · Cleared
Recalled · Class II · 2017Syngo.X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens AG Medical Solutions · LLZ System, Image Processing, Radiological
Cleared on Aug 27, 2009 as substantially equivalent to K081734 (Siemens AG Medical Solutions, 2008) and 1 other predicate after a 9-day review. Its family tree reaches back 6 generations to 1997. 1 of the 192 devices in its family, counting itself, has a Class I recall. 176 later devices descend from it. It has been recalled 4 times.
- Decided
- Aug 27, 2009
- Review
- 9 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 6 generations to K971684 (1997). 15 ancestors in all, the oldest K970852 (1997). 176 later devices descend from it, 11 citing it directly. 1 of the 192 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 5 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 4 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 3 generations backK052423 Magnetom Systems with Syngo Expert - I OptionSiemens Medi Cal Solutions, Inc. · 2006
- 2 generations backK061964 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2006
- 1 generation backK072728 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2008
- This deviceK092519 Syngo.XSiemens AG Medical Solutions · 2009
- Descendant · cites it directly · 99 of its ownK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- Descendant · 2 generations on · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- Descendant · cites it directly · 54 of its ownK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
- Descendant · 3 generations on · 46 of its ownK150843 syngo®.via (version VB10A)Siemens AG · 2015
- Descendant · cites it directly · 25 of its ownK110366 Syngo.CT Cardiac FunctionSiemens AG · 2011 · Recalled
Showing 5 of 176 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…5 generations on · 2025
Most influential descendants
Showing 5 of 176 · See all- K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011 · cites it directly99descendants
- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · 2 generations on63descendants
- K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010 · cites it directly54descendants
- K150843syngo®.via (version VB10A)Siemens AG · 2015 · 3 generations on46descendants
- K110366Syngo.CT Cardiac FunctionSiemens AG · 2011 · cites it directly25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −5 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −4 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −3 | K052423 | Magnetom Systems with Syngo Expert - I Option | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −2 | K061964 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2006 | — |
| −1 | K072728 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2008 | — |
| 0 (this device) | K092519 | Syngo.X | Siemens AG Medical Solutions | 2009 | — |
| +1 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| +2 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| +1 | K093621 | Syngo.Pet&CT Oncology | Siemens Medical Solutions USA, Inc. | 2010 | — |
| +3 | K150843 | syngo®.via (version VB10A) | Siemens AG | 2015 | — |
| +1 | K110366 | Syngo.CT Cardiac Function | Siemens AG | 2011 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 6 | 0 |
| 2013 | 6 | 0 |
| 2014 | 4 | 0 |
| 2015 | 8 | 0 |
| 2016 | 7 | 0 |
| 2017 | 6 | 0 |
| 2018 | 12 | 0 |
| 2019 | 11 | 0 |
| 2020 | 22 | 0 |
| 2021 | 8 | 0 |
| 2022 | 16 | 0 |
| 2023 | 17 | 0 |
| 2024 | 15 | 0 |
| 2025 | 15 | 1 |
| 2026 | 15 | 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.
1 device in this family has a Class I recall. 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 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 |
|---|---|---|---|
| * | K081734 | Syngo Imaging (Version V31)Summary page 4…mCer FD Number K081734 Siemens syngo Imaging Siemens syngo MultiModality Workplace K072728 T… | 2008 |
| * | K072728 | Syngo Multimodality WorkplaceSummary page 2…. syngo.x allows to use a variety of advanced applications (clinical applica- tions) designed for syngo.x just as the predicate device syngo MultiMo- dality Workplace (K072728, cleared on April 22, 2007). These applica- tions are medical devices on their own rights and filed separately. They are not part… | 2008 |
What descends from it? (176)
See all 17611 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112020 | Syngo.CT Vascular Analysis | 2011 | 99 |
| K093621 | Syngo.Pet&CT Oncology | 2010 | 54 |
| K110366 | Syngo.CT Cardiac Function | 2011 | 25 |
| K120315 | Syngo.MR Spectro Engine, Syngo.MR Spectro SVS, Syngo.MR Spectro Csi, Syngo.MR Spectro… | 2012 | 23 |
| K113029 | Syngo Via MI Workflows | 2011 | 20 |
| K101666 | Syngo. Plaza VA20A | 2010 | 9 |
| K121459 | Syngo.MR Neurology | 2012 | 3 |
| K100637 | Syngo.CT Coronary Analysis | 2010 | 2 |
| K111079 | Syngo.Via Web Viewer | 2011 | 1 |
| K120363 | Syngo RT Interface | 2012 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 6, 2017 | Class II | Z-1688-2017 | Software design | Software changes now available to address several issues |
| Aug 5, 2016 | Class II | Z-2852-2016 | Software design | Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too high. |
| Jun 23, 2016 | Class II | Z-2245-2016 | Software design | Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors. |
| May 15, 2015 | Class II | Z-1705-2015 | Software design | measurements drawn on the 2nd and subsequent images of the series are not visible on printouts when the series is sent to print. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 5 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 10 of the 15 ancestors have a recall of any class.
- Of its descendants, K112020 (Siemens Medi Cal Solutions, Inc., 2011) has gone furthest, with 99 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo.x based software options.
syngo.x supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.
The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092519 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092519: Syngo.X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092519
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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