510(k) · Cleared
ClearedSyngo.Via
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 Jan 18, 2013 as substantially equivalent to K123375 (Siemens AG, 2012) and 4 other predicates after a 29-day review. Its family tree reaches back 10 generations to 1991. 4 of the 244 devices in its family, counting itself, have a Class I recall. 63 later devices descend from it.
- Decided
- Jan 18, 2013
- Review
- 29 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K913770 (1991). 180 ancestors in all, the oldest K837107 (1983). 63 later devices descend from it, 5 citing it directly. 4 of the 244 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations between
- 3 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 1 generation backK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- This deviceK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- Descendant · cites it directly · 46 of its ownK150843 syngo®.via (version VB10A)Siemens AG · 2015
- Descendant · 2 generations on · 23 of its ownK163294 syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc. · 2017
- Descendant · 3 generations on · 21 of its ownK180336 syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2018
- Descendant · 4 generations on · 14 of its ownK182904 syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2019
- Descendant · 5 generations on · 11 of its ownK193290 AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc. · 2020
Show all 10 generations
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 8 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 7 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 6 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 5 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 4 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 3 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 1 generation backK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- This deviceK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 63 · See all- K150843syngo®.via (version VB10A)Siemens AG · 2015 · cites it directly46descendants
- K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc. · 2017 · 2 generations on23descendants
- K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2018 · 3 generations on21descendants
- K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2019 · 4 generations on14descendants
- K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc. · 2020 · 5 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −9 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −8 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −7 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −6 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −5 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −4 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −3 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −2 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −1 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| 0 (this device) | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| +1 | K150843 | syngo®.via (version VB10A) | Siemens AG | 2015 | — |
| +2 | K163294 | syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology | Siemens Medical Solutions USA, Inc. | 2017 | — |
| +3 | K180336 | syngo.MR Applications | Siemens Medical Solutions USA, Inc. | 2018 | — |
| +4 | K182904 | syngo.MR Applications | Siemens Medical Solutions USA, Inc. | 2019 | — |
| +5 | K193290 | AI-Rad Companion Brain MR | Siemens Medical Solutions USA, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 9 | 0 |
| 1998 | 12 | 0 |
| 1999 | 6 | 0 |
| 2000 | 11 | 0 |
| 2001 | 17 | 0 |
| 2002 | 13 | 0 |
| 2003 | 8 | 0 |
| 2004 | 15 | 0 |
| 2005 | 11 | 0 |
| 2006 | 10 | 0 |
| 2007 | 8 | 1 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 1 |
| 2011 | 4 | 0 |
| 2012 | 3 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 9 | 0 |
| 2022 | 4 | 0 |
| 2023 | 8 | 0 |
| 2024 | 8 | 0 |
| 2025 | 10 | 1 |
| 2026 | 8 | 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.
4 devices in this family have 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? (5)
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 |
|---|---|---|---|
| * | K123375 | Syngo.ViaSummary page 13…FDA Clearance facturer PredicateDevice Name Number Siemens syn go via K123375 Siemens SOMATOM Definition Edge CT System K120579 Siemens syngo.CT Vascular Analysis… | 2012 |
| * | K120579 | Somatom Definition EdgeSummary page 13…Number Siemens syn go via K123375 Siemens SOMATOM Definition Edge CT System K120579 Siemens syngo.CT Vascular Analysis 112020 Siemens Software syngo MR D13A for MAGNTO… | 2012 |
| * | K112020 | Syngo.CT Vascular AnalysisSummary page 13…K123375 Siemens SOMATOM Definition Edge CT System K120579 Siemens syngo.CT Vascular Analysis 112020 Siemens Software syngo MR D13A for MAGNTOM K121434 __________ systemsAera/SkyratAvanto/Verio… | 2011 |
| * | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSummary page 13…tem K120579 Siemens syngo.CT Vascular Analysis 112020 Siemens Software syngo MR D13A for MAGNTOM K121434 __________ systemsAera/SkyratAvanto/Verio Siemens syngo TrueD K10 1749… | 2012 |
| * | K101749 | Syngo Trued SoftwareSummary page 13…are syngo MR D13A for MAGNTOM K121434 __________ systemsAera/SkyratAvanto/Verio Siemens syngo TrueD K10 1749 The added capabilities to syngo.via described in this 5 10(k) has similar functional- ities that can be found in the devices lis… | 2010 |
What descends from it? (63)
See all 635 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
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.
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · Direct predicate · ◆ in the 2012 ancestors bar of FIG. 12 Class I recalls
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 3 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 3 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 43 of the 180 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K150843 (Siemens AG, 2015) has gone furthest, with 46 descendants of its own.
- 2 other devices also cite its predicate K123375.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
syngovia 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K123920 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123920: Syngo.Via.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123920
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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