510(k) · Cleared
ClearedSyngo Trued, Model VC10A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions · LLZ System, Image Processing, Radiological
Cleared on Jun 29, 2006 as substantially equivalent to K041182 (Adac Laboratories, 2004) and 2 other predicates after a 15-day review. Its family tree reaches back 7 generations to 1995. 11 later devices descend from it.
- Decided
- Jun 29, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K945512 (1995). 29 ancestors in all, the oldest K871859 (1987). 11 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 6 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
- 5 generations backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
- 4 generations backK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
- 3 generations backK022919 Smart Breath Respiratory Compensation OptionGE Medical Systems · 2002
- 2 generations backK032915 Advantage 4D OptionGe Medical Systems, LLC · 2003
- 1 generation backK052345 Advantage Sim MDGE Healthcare · 2005 · Recalled
- This deviceK061671 Syngo Trued, Model VC10ASiemens Medical Solutions · 2006
- Descendant · cites it directly · 9 of its ownK071241 LMS-LiverMedian Technologies · 2007
- Descendant · 2 generations on · 8 of its ownK121213 VitreaadvancedVital Images, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 5 of its ownK142521 Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014
- Descendant · 4 generations on · 4 of its ownK151988 Visible Patient SuiteVisible Patient, Sas · 2015
- Descendant · 5 generations on · 3 of its ownK212896 Visible Patient SuiteVisible Patient, Sas · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K071241LMS-LiverMedian Technologies · 2007 · cites it directly9descendants
- K121213VitreaadvancedVital Images, Inc. · 2012 · 2 generations on8descendants
- K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014 · 3 generations on5descendants
- K151988Visible Patient SuiteVisible Patient, Sas · 2015 · 4 generations on4descendants
- K212896Visible Patient SuiteVisible Patient, Sas · 2021 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945512 | HRSW Option for CT Twin Flash | Elscint, Inc. | 1995 | — |
| −6 | K970980 | Cardiac Scoring for CT Scanners | Elscint, Inc. | 1997 | — |
| −5 | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows | General Electric Co. | 1998 | — |
| −4 | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 | GE Medical Systems | 2002 | — |
| −3 | K022919 | Smart Breath Respiratory Compensation Option | GE Medical Systems | 2002 | — |
| −2 | K032915 | Advantage 4D Option | Ge Medical Systems, LLC | 2003 | — |
| −1 | K052345 | Advantage Sim MD | GE Healthcare | 2005 | 3 |
| 0 (this device) | K061671 | Syngo Trued, Model VC10A | Siemens Medical Solutions | 2006 | — |
| +1 | K071241 | LMS-Liver | Median Technologies | 2007 | — |
| +2 | K121213 | Vitreaadvanced | Vital Images, Inc. | 2012 | 1 |
| +3 | K142521 | Synapse 3D Liver and Kidney Analysis | Fujifilm Meidcal Systems U.S.A.,Inc. | 2014 | — |
| +4 | K151988 | Visible Patient Suite | Visible Patient, Sas | 2015 | — |
| +5 | K212896 | Visible Patient Suite | Visible Patient, Sas | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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 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? (3)
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 |
|---|---|---|---|
| * | K041182 | SyntegraSummary page 2…devices[onm4l: FDA ClearanceNumber Syntegra Gamma Camera System K041 182 GE Advantage Sim 6.0 K021780 GE Advantage MD… | 2004 |
| * | K021780 | Advantage Sim 6.0Summary page 2…FDA ClearanceNumber Syntegra Gamma Camera System K041 182 GE Advantage Sim 6.0 K021780 GE Advantage MD K052345 In summary, Siemens is of the opinion that the ind… | 2002 |
| * | K052345 | Advantage Sim MDSummary page 2…K041 182 GE Advantage Sim 6.0 K021780 GE Advantage MD K052345 In summary, Siemens is of the opinion that the indicated change to the syngo TrueD software, as described within this submission… | 2005 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 13 of the 29 ancestors have a recall of any class.
- Of its descendants, K071241 (Median Technologies, 2007) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K041182.
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?
syngo TrueD is a medical diagnostic application 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. The images can be viewed in a number of output formats including MIP and volume rendering. syngo TrueD enables visualization of information that would…
Read the full statement (222 words)
syngo TrueD is a medical diagnostic application 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. The images can be viewed in a number of output formats including MIP and volume rendering.
syngo TrueD enables visualization of information that would otherwise have to be visually compared disjointedly. syngo TrueD provides analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations.
syngo TrueD is designed to support the oncological workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions. The application allows to store and export volume of interest (VOl) structures in DICOM RT format for use in radiation therapy planning systems.
syngo TrueD allows visualization and analysis of respiratory gated studies to support accurate delineation of the target or treatment volume over a defined phase of the respiratory cycle and thus provide information for radiationtherapy planning.
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 TrueD is a complement to these standard procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061671 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061671: Syngo Trued, Model VC10A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061671
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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