510(k) · Cleared
Recalled · Class II · 2018Syngo.Via
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens AG · LLZ System, Image Processing, Radiological
Cleared on Nov 20, 2012 after a 19-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 of the 97 devices in its family, counting itself, has a Class I recall. 96 later devices descend from it. It has been recalled 8 times.
- Decided
- Nov 20, 2012
- Review
- 19 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 8
- Predicates
- 1
96 later devices descend from it, 3 citing it directly. 1 of the 97 devices in this family, counting this one, has a Class I recall.
- This deviceK123375 Syngo.ViaSiemens AG · 2012
- Descendant · cites it directly · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- Descendant · cites it directly · 54 of its ownK130749 Syngo.MR General; Syngo.MR Cardiology; Syngo.MR VascularSiemens Medical Solutions USA, Inc. · 2013
- Descendant · 2 generations on · 46 of its ownK150843 syngo®.via (version VB10A)Siemens AG · 2015
- Descendant · 2 generations on · 27 of its ownK133401 Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR…Siemens Medical Solutions USA, Inc. · 2014
- Descendant · 3 generations on · 25 of its ownK151353 syngo.MR Neurology, syngo.MR OncologySiemens Medical Solutions USA, Inc. · 2015
Showing 5 of 96 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…4 generations on · 2025
Most influential descendants
Showing 5 of 96 · See all- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · cites it directly63descendants
- K130749Syngo.MR General; Syngo.MR Cardiology; Syngo.MR VascularSiemens Medical Solutions USA, Inc. · 2013 · cites it directly54descendants
- K150843syngo®.via (version VB10A)Siemens AG · 2015 · 2 generations on46descendants
- K133401Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR GeneralSiemens Medical Solutions USA, Inc. · 2014 · 2 generations on27descendants
- K151353syngo.MR Neurology, syngo.MR OncologySiemens Medical Solutions USA, Inc. · 2015 · 3 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K123375 | Syngo.Via | Siemens AG | 2012 | — |
| +1 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| +1 | K130749 | Syngo.MR General; Syngo.MR Cardiology; Syngo.MR Vascular | Siemens Medical Solutions USA, Inc. | 2013 | — |
| +2 | K150843 | syngo®.via (version VB10A) | Siemens AG | 2015 | — |
| +2 | K133401 | Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR General | Siemens Medical Solutions USA, Inc. | 2014 | — |
| +3 | K151353 | syngo.MR Neurology, syngo.MR Oncology | Siemens Medical Solutions USA, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2019 | 7 | 0 |
| 2020 | 10 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 14 | 0 |
| 2024 | 8 | 0 |
| 2025 | 12 | 1 |
| 2026 | 11 | 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? (1)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K092551 | FDA’s K092551 is Smith & Nephew Instrument Trays Our reading of the summary gave K092551, FDA’s number for Smith & Nephew Instrument Trays (Smith & Nephew Inc., Endoscopy Div.). Its FDA name has none of the distinctive words the summary uses for the device it names, “syngo.x”. Kept off the family tree. Summary page 2…cific workflows. syngo.via allows to use a variety of advanced applications (clinical applica- tions) designed for syngo.via just as the predicate device .syngo.x,(K09255 19, cleared on August 27, 2009). These applications are medical devices on theft own rights and filed separately. They are no… | 2010 |
What descends from it? (96)
See all 963 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 27, 2018 | Class II | Z-1778-2018 | Software design | Functionality in the report sections "Findings Information" and "Summary of Measured Findings" not functioning properly. The corrected values modified in the report are neither saved, nor printed, nor sent to the information system. The… |
| Jan 10, 2018 | Class II | Z-1261-2018 | Software Manufacturing/Software Deployment | When the archiving configuration is changed, data received/created after the upgrade may be flagged as "Not to be archived". This is caused by the automatic function for cleaning up temporary data being disabled by the software upgrade.… |
| Jan 8, 2018 | Class II | Z-1303-2018 | Software design | A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving corrected/modified values. Outdated… |
| Aug 31, 2017 | Class II | Z-0808-2018 | Software Design Change | A software update was released on August 22, 2017. Performing this software installation and upgrading syngo.via system to the software version VB20A_HF02 will resolve various bugs and inconsistent diagnosis with the old system. |
| Mar 6, 2017 | Class II | Z-1689-2017 | Software design | Software changes now available to address several issues |
| Aug 5, 2016 | Class II | Z-2853-2016 | 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. |
The 5 latest of 8 recalls; the web page lists all.
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 · 4 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K123920 (Siemens AG Medical Solutions, 2013) has gone furthest, with 63 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. 2012, 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.via 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 based software options.
syngo.via 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/K123375 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123375: Syngo.Via.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123375
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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