510(k) · Cleared
ClearedSyngo Multimodality Workplace
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 Jul 27, 2006 as substantially equivalent to K052775 (Siemens AG Medical Solutions, 2005) and 1 other predicate after a 15-day review. Its family tree reaches back 4 generations to 1997. 1 of the 192 devices in its family, counting itself, has a Class I recall. 180 later devices descend from it.
- Decided
- Jul 27, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K971684 (1997). 11 ancestors in all, the oldest K970852 (1997). 180 later devices descend from it, 2 citing it directly. 1 of the 192 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 3 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 2 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 1 generation backK052423 Magnetom Systems with Syngo Expert - I OptionSiemens Medi Cal Solutions, Inc. · 2006
- This deviceK061964 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2006
- Descendant · cites it directly · 178 of its ownK072728 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2008
- Descendant · cites it directly · 177 of its ownK081734 Syngo Imaging (Version V31)Siemens AG Medical Solutions · 2008 · Recalled
- Descendant · 2 generations on · 176 of its ownK092519 Syngo.XSiemens AG Medical Solutions · 2009 · Recalled
- Descendant · 3 generations on · 99 of its ownK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- Descendant · 4 generations on · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
Showing 5 of 180 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 180 · See all- K072728Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2008 · cites it directly178descendants
- K081734Syngo Imaging (Version V31)Siemens AG Medical Solutions · 2008 · cites it directly177descendants
- K092519Syngo.XSiemens AG Medical Solutions · 2009 · 2 generations on176descendants
- K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011 · 3 generations on99descendants
- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · 4 generations on63descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −3 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −2 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −1 | K052423 | Magnetom Systems with Syngo Expert - I Option | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| 0 (this device) | K061964 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2006 | — |
| +1 | K072728 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2008 | — |
| +1 | K081734 | Syngo Imaging (Version V31) | Siemens AG Medical Solutions | 2008 | 5 |
| +2 | K092519 | Syngo.X | Siemens AG Medical Solutions | 2009 | 4 |
| +3 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| +4 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 6 | 0 |
| 2013 | 7 | 0 |
| 2014 | 4 | 0 |
| 2015 | 8 | 0 |
| 2016 | 7 | 0 |
| 2017 | 6 | 0 |
| 2018 | 12 | 0 |
| 2019 | 11 | 0 |
| 2020 | 22 | 0 |
| 2021 | 8 | 0 |
| 2022 | 16 | 0 |
| 2023 | 17 | 0 |
| 2024 | 15 | 0 |
| 2025 | 15 | 1 |
| 2026 | 15 | 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? (2)
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 |
|---|---|---|---|
| * | K052775 | Syngo Multimodality Workplace (Syngo MM WP)Summary page 2…addressed in this premarket notification, is substantially equivalent to the following commercially available device: syngo MultiModality Workplac (K052775) MAGNETOM Systems with Expert-i option (K052423) The syngo MultiModality Workplace described in this premark… | 2005 |
| * | K052423 | Magnetom Systems with Syngo Expert - I OptionSummary page 2…ntially equivalent to the following commercially available device: syngo MultiModality Workplac (K052775) MAGNETOM Systems with Expert-i option (K052423) The syngo MultiModality Workplace described in this premarket notification has the same intended use and simila… | 2006 |
What descends from it? (180)
See all 1802 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)
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.
- 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?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 8 of the 11 ancestors have a recall of any class.
- Of its descendants, K072728 (Siemens AG Medical Solutions, 2008) has gone furthest, with 178 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 | — |
What is it indicated for?
The syngo MultiModality Workplace is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media.
The syngo MultiModality Workplace can be configured as a stand-alone diagnostic review and post-processing workplace with a variety of syngo- or Windows XP-based software options, that are intended to assist the physician in diagnosis, surgical planning, interventional procedures or treatment planning. These options include commercially available post-processing software.
The syngo MultiModality Workplace does not support the display of mammography images for diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061964 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061964: Syngo Multimodality Workplace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061964
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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