510(k) · Cleared
Recalled · 2008Syngo Multimodality Workstation
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 Jun 26, 2001 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 722 devices in its family, counting itself, has a Class I recall. 721 later devices descend from it. It has been recalled 5 times.
- Decided
- Jun 26, 2001
- Review
- 89 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 5
- Predicates
- 0
721 later devices descend from it, 13 citing it directly. 1 of the 722 devices in this family, counting this one, has a Class I recall.
- This deviceK010938 Syngo Multimodality WorkstationSiemens Medical Solutions USA, Inc. · 2001
- Descendant · cites it directly · 420 of its ownK040970 LeonardoSiemens Medical Systems, Inc. · 2004 · Recalled
- Descendant · cites it directly · 263 of its ownK063762 Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2007
- Descendant · cites it directly · 227 of its ownK030982 Syngo Colonography Software PackageSiemens Medical Solutions USA, Inc. · 2003
- Descendant · cites it directly · 222 of its ownK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- Descendant · 2 generations on · 221 of its ownK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
Showing 5 of 721 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…7 generations on · 2025
Most influential descendants
Showing 5 of 721 · See all- K040970LeonardoSiemens Medical Systems, Inc. · 2004 · cites it directly420descendants
- K063762Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2007 · cites it directly263descendants
- K030982Syngo Colonography Software PackageSiemens Medical Solutions USA, Inc. · 2003 · cites it directly227descendants
- K041484UndecidedSiemens Medical Solutions USA, Inc. · 2004 · cites it directly222descendants
- K053301Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006 · 2 generations on221descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010938 | Syngo Multimodality Workstation | Siemens Medical Solutions USA, Inc. | 2001 | — |
| +1 | K040970 | Leonardo | Siemens Medical Systems, Inc. | 2004 | 1 |
| +1 | K063762 | Syngo Circulation Software Package with Extended Functionality | Siemens AG Medical Solutions | 2007 | — |
| +1 | K030982 | Syngo Colonography Software Package | Siemens Medical Solutions USA, Inc. | 2003 | — |
| +1 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +2 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 7 | 0 |
| 2005 | 8 | 0 |
| 2006 | 11 | 0 |
| 2007 | 9 | 0 |
| 2008 | 7 | 0 |
| 2009 | 16 | 0 |
| 2010 | 15 | 0 |
| 2011 | 21 | 0 |
| 2012 | 27 | 0 |
| 2013 | 19 | 0 |
| 2014 | 21 | 0 |
| 2015 | 23 | 0 |
| 2016 | 24 | 0 |
| 2017 | 32 | 0 |
| 2018 | 45 | 0 |
| 2019 | 40 | 0 |
| 2020 | 52 | 0 |
| 2021 | 43 | 0 |
| 2022 | 55 | 0 |
| 2023 | 53 | 0 |
| 2024 | 53 | 0 |
| 2025 | 74 | 1 |
| 2026 | 61 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (721)
See all 72113 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040970 | Leonardo | 2004 | 420 |
| K063762 | Syngo Circulation Software Package with Extended Functionality | 2007 | 263 |
| K030982 | Syngo Colonography Software Package | 2003 | 227 |
| K041484 | Undecided | 2004 | 222 |
| K071310 | Syngo CT Oncology Software Package | 2007 | 195 |
| K080968 | S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan Opera | 2008 | 24 |
| K031764 | Oncor Avant-Garde with Coherence Workspaces | 2003 | 16 |
| K080529 | Stereos Workstation | 2008 | 14 |
| K033831 | Sienet Cosmos | 2003 | 6 |
| K052467 | Brain Viewrx Viewer, Version 1.0 | 2005 | 5 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 12, 2008 | Not classified | Z-0324-2009 | Software design | Values derived from Dynamic CT data sets may be incorrect. The corresponding images are not affected. |
| Sep 28, 2004 | Not classified | Z-0163-05 | Other | Calcium Scoring feature on this devices is not closing properly after patient's exams. |
| Feb 28, 2003 | Not classified | Z-1089-03 | Other | software problem This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment. |
| Feb 28, 2003 | Not classified | Z-1088-03 | Other | software problem This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment. |
| Oct 11, 2002 | Not classified | Z-0841-03 | Other | Perfusion CT is displaying a higher gray and color values than normal. A software problem. |
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 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K040970 (Siemens Medical Systems, Inc., 2004) has gone furthest, with 420 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.
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 | — |
https://510kreport.com/device/K010938 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010938: Syngo Multimodality Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010938
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026