510(k) · Cleared
Clearedsyngo.via MI WorkFlows, Scenium, syngo MBF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Jun 10, 2021 as substantially equivalent to K201195 (Siemens Medical Solutions USA, Inc., 2020) after a 30-day review. Its family tree reaches back 19 generations to 1991. 4 later devices descend from it.
- Decided
- Jun 10, 2021
- Review
- 30 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K913770 (1991). 147 ancestors in all, the oldest K871859 (1987). 4 later devices descend from it, 1 citing it directly.
- Root · 19 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 15 generations between
- 3 generations backK173897 syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2018
- 2 generations backK191309 syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc. · 2019
- 1 generation backK201195 syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc. · 2020
- This deviceK211459 syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK232000 syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK242275 syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK251528 syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc. · 2025
- Descendant · 4 generations on · 0 of its ownK254016 MI View&GOSiemens Medical Solutions USA, Inc. · 2026
Show all 19 generations
- Root · 19 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 18 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 17 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 16 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 15 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 14 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 13 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 12 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 11 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 10 generations backK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
- 9 generations backK113029 Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2011
- 8 generations backK123577 Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2013
- 7 generations backK133644 Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2014
- 6 generations backK151192 syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2015
- 5 generations backK160426 syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2016
- 4 generations backK163421 syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2017
- 3 generations backK173897 syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2018
- 2 generations backK191309 syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc. · 2019
- 1 generation backK201195 syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc. · 2020
- This deviceK211459 syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc. · 2021
Most influential descendants
Showing 4 of 4 · See all- K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc. · 2023 · cites it directly3descendants
- K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc. · 2024 · 2 generations on2descendants
- K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc. · 2025 · 3 generations on1descendant
- K254016MI View&GOSiemens Medical Solutions USA, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −18 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −17 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −16 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −15 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −14 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −13 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −12 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −11 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −10 | K093621 | Syngo.Pet&CT Oncology | Siemens Medical Solutions USA, Inc. | 2010 | — |
| −9 | K113029 | Syngo Via MI Workflows | Siemens Medical Solutions USA, Inc. | 2011 | — |
| −8 | K123577 | Syngo.Via MI Workflows | Siemens Medical Solutions USA, Inc. | 2013 | — |
| −7 | K133644 | Syngo.Via MI Workflows | Siemens Medical Solutions USA, Inc. | 2014 | — |
| −6 | K151192 | syngo.via MI Workflows | Siemens Medical Solutions USA, Inc. | 2015 | — |
| −5 | K160426 | syngo.via MI Workflows | Siemens Medical Solutions USA, Inc. | 2016 | — |
| −4 | K163421 | syngo.via MI Workflows | Siemens Medical Solutions USA, Inc. | 2017 | — |
| −3 | K173897 | syngo.via MI Workflows | Siemens Medical Solutions USA, Inc. | 2018 | — |
| −2 | K191309 | syngo.via MI Workflows VB40A, Scenium | Siemens Medical Soultions USA, Inc. | 2019 | — |
| −1 | K201195 | syngo.via MI Workflows, syngo MBF | Siemens Medical Solutions USA, Inc. | 2020 | — |
| 0 (this device) | K211459 | syngo.via MI WorkFlows, Scenium, syngo MBF | Siemens Medical Solutions USA, Inc. | 2021 | — |
| +1 | K232000 | syngo.via MI Workflows; Scenium; syngo MBF | Siemens Medical Solutions USA, Inc. | 2023 | — |
| +2 | K242275 | syngo.via MI Workflows; Scenium; syngo MBF | Siemens Medical Solutions USA, Inc. | 2024 | — |
| +3 | K251528 | syngo.via MI Workflows; Scenium; syngo MBF | Siemens Medical Solutions USA, Inc. | 2025 | — |
| +4 | K254016 | MI View&GO | Siemens Medical Solutions USA, Inc. | 2026 | — |
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 | 4 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.6 · 7 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 |
|---|---|---|---|
| * | K201195 | syngo.via MI Workflows, syngo MBFSummary page 5…evice Class: Class II Manufacturer: Siemens Medical Solutions USA, inc. 510(k) Number: K201195 (November 2020) syngo.via MI Workflows VB50A is deemed the primary predicate device due to it being the most similar to the de… | 2020 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232000 | syngo.via MI Workflows; Scenium; syngo MBF | 2023 | 3 |
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 30 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 33 of the 147 ancestors have a recall of any class.
- Of its descendants, K232000 (Siemens Medical Solutions USA, Inc., 2023) has gone furthest, with 3 descendants of its own.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
syngo.via molecular imaging (MI) workflows comprise medical diagnostic applications for viewing, manipulation, quantification, analysis and comparison of medical images from single or multiple imaging modalities with one or more time-points. These workflows support functional data, such as positron emission tomography (PET) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR). syngo.via MI…
Read the full statement (131 words)
syngo.via molecular imaging (MI) workflows comprise medical diagnostic applications for viewing, manipulation, quantification, analysis and comparison of medical images from single or multiple imaging modalities with one or more time-points. These workflows support functional data, such as positron emission tomography (PET) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR). syngo.via MI workflows can perform harmonization of SUV (PET) across different PET systems or different PET reconstruction methods.
syngo.via MI workflows are intended to be utilized by appropriately trained health care professionals to aid in the management of diseases, including those associated with oncology, cardiology, neurology, and organ function. The images and results produced by the syngo.via MI workflows can also be used by the physician to aid in radiotherapy treatment planning.
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/K211459 · printed Nov 3, 2026
Cite this page
510(k) Report. “K211459: syngo.via MI WorkFlows, Scenium, syngo MBF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K211459
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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