510(k) · Cleared
Clearedsyngo.via MI Workflows
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · LLZ System, Image Processing, Radiological
Cleared on Feb 29, 2016 as substantially equivalent to K151192 (Siemens Medical Solutions USA, Inc., 2015) after a 24-day review. Its family tree reaches back 14 generations to 1991.
- Decided
- Feb 29, 2016
- Review
- 24 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K913770 (1991). 139 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 14 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations between
- 3 generations backK123577 Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2013
- 2 generations backK133644 Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2014
- 1 generation backK151192 syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2015
- This deviceK160317 syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2016
Show all 14 generations
- Root · 14 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 13 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 12 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 11 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 10 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 9 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 8 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 7 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 6 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 5 generations backK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
- 4 generations backK113029 Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2011
- 3 generations backK123577 Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2013
- 2 generations backK133644 Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2014
- 1 generation backK151192 syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2015
- This deviceK160317 syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −13 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −12 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −11 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −10 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −9 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −8 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −7 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −6 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −5 | K093621 | Syngo.Pet&CT Oncology | Siemens Medical Solutions USA, Inc. | 2010 | — |
| −4 | K113029 | Syngo Via MI Workflows | Siemens Medical Solutions USA, Inc. | 2011 | — |
| −3 | K123577 | Syngo.Via MI Workflows | Siemens Medical Solutions USA, Inc. | 2013 | — |
| −2 | K133644 | Syngo.Via MI Workflows | Siemens Medical Solutions USA, Inc. | 2014 | — |
| −1 | K151192 | syngo.via MI Workflows | Siemens Medical Solutions USA, Inc. | 2015 | — |
| 0 (this device) | K160317 | syngo.via MI Workflows | Siemens Medical Solutions USA, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 11 | 0 |
| 1999 | 5 | 0 |
| 2000 | 8 | 0 |
| 2001 | 13 | 0 |
| 2002 | 11 | 0 |
| 2003 | 5 | 0 |
| 2004 | 12 | 0 |
| 2005 | 9 | 0 |
| 2006 | 7 | 0 |
| 2007 | 6 | 0 |
| 2008 | 3 | 0 |
| 2009 | 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 LLZ? 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K151192 | syngo.via MI WorkflowsSummary page 5…hich Equivalence is claimed Device Manufacturer 510(k) Number syngo.via MI Siemens Medical Solutions USA, Inc K151192 (June 2015) Workflows VB10A Device Description The Total Lesion Glycolysis (TLG) feature resides within syngo.via MI Workflo… | 2015 |
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 25 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 33 of the 139 ancestors have a recall of any class.
- 1 other device also cites its predicate K151192.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 MI Workflows are medical diagnostic applications for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows…
Read the full statement (165 words)
syngo.via MI Workflows are medical diagnostic applications for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR.
syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo.via MI Workflows can perform harmonization of SUV (PET) across different PET systems or different reconstruction methods.
syngo.via MI workflows support the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo.via MI Workflows are a complement to these standard procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160317 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160317: syngo.via MI Workflows.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160317
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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