510(k) · Cleared
ClearedSynapse 3D Cardiac Tools
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Medical System U.S.A., Inc. · LLZ System, Image Processing, Radiological
Cleared on Apr 9, 2013 as substantially equivalent to K120636 (Fujifilm Medical System U.S.A., Inc., 2012) and 1 other predicate after a 54-day review. Its family tree reaches back 12 generations to 1991. 5 later devices descend from it.
- Decided
- Apr 9, 2013
- Review
- 54 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K913770 (1991). 66 ancestors in all, the oldest K871859 (1987). 5 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations between
- 3 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 2 generations backK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
- 1 generation backK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
- This deviceK130383 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2013
- Descendant · cites it directly · 4 of its ownK200973 Synapse 3D Cardiac ToolsFujifilm Corporaton · 2020
- Descendant · 2 generations on · 1 of its ownK220039 AutoSegAi Medic, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK220727 inHEART MODELSInheart, Sas · 2022
- Descendant · 3 generations on · 0 of its ownK243158 TeraRecon Aorta.CT (1.1.0)Terarecon,Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK231683 inHEART ModelsInheart, Sas · 2024
Show all 12 generations
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 11 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 10 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 9 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 8 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 7 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 6 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 5 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 4 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 3 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 2 generations backK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
- 1 generation backK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
- This deviceK130383 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2013
Most influential descendants
Showing 5 of 5 · See all- K200973Synapse 3D Cardiac ToolsFujifilm Corporaton · 2020 · cites it directly4descendants
- K220039AutoSegAi Medic, Inc. · 2022 · 2 generations on1descendant
- K220727inHEART MODELSInheart, Sas · 2022 · 2 generations on1descendant
- K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc. · 2025 · 3 generations on0descendants
- K231683inHEART ModelsInheart, Sas · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −11 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −10 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −9 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −8 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −7 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −6 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −5 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −4 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −3 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| −2 | K073156 | Qplaque MR | Medis Medical Imaging Systems BV | 2008 | — |
| −1 | K120636 | Synapse 3D Cardiac Tools | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| 0 (this device) | K130383 | Synapse 3D Cardiac Tools | Fujifilm Medical System U.S.A., Inc. | 2013 | — |
| +1 | K200973 | Synapse 3D Cardiac Tools | Fujifilm Corporaton | 2020 | — |
| +2 | K220039 | AutoSeg | Ai Medic, Inc. | 2022 | — |
| +2 | K220727 | inHEART MODELS | Inheart, Sas | 2022 | — |
| +3 | K243158 | TeraRecon Aorta.CT (1.1.0) | Terarecon,Inc. | 2025 | — |
| +3 | K231683 | inHEART Models | Inheart, Sas | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K120636 | Synapse 3D Cardiac ToolsSummary page 2…bmission Page24 of1411 FUJIFILM Medical Systems U.S.A., Inc. Synapse 3D Cardiac Tools (V3.2) 510O(k) Predicate Device: *Synapse 3D Cardiac Tools (K120636), FUJIFILM Medical Systems U.S.A., Inc. *3mensio Structural Heart /Vascular (K1I20367), Pie Medical Imaging BV Description o… | 2012 |
| * | K120367 | 3MENSIO WorkstationSummary page 4…nological Characteristics The proposed Synapse 3D Cardiac Tools and the predicate devices, Synapse 3D Cardiac Tools (K1 02636) and 3mensio Structural Heart / Vascular (K1 20367), are medical application software running on Windows operating system installed on commercial general-purpose Windows- compati… | 2012 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200973 | Synapse 3D Cardiac Tools | 2020 | 4 |
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 22 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 10 of the 66 ancestors have a recall of any class.
- Of its descendants, K200973 (Fujifilm Corporaton, 2020) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K120636.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Synapse 3D Cardiac Tools is medical imaging software used with Synapse 3D Base Tools that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Cardiac Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including, CT, MR, NMv, and XA. This product is not intended for use with or for the primary diagnostic interpretation of…
Read the full statement (284 words)
Synapse 3D Cardiac Tools is medical imaging software used with Synapse 3D Base Tools that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Cardiac Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including, CT, MR, NMv, and XA.
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
Addition to the tools in Synapse 3D Base Tools, Synapse 3D Cardiac Tools provides the tools for specific clinical applications which provide targeted workflows, custom UI, targeted measurements and reporting functions including:
>Functional cardiac analysis for CT left ventriculography images: which is intended to evaluate the functional characteristics of heart
>Functional cardiac analysis for non-contrast MR heart images: which is intended to evaluate the functional characteristics of heart
> Coronary artery analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries
> Coronary artery analysis for MR heart images: which is intended for the qualitative and quantitative analysis of coronary arteries
> Calcium scoring for non-contrast CT heart images: which is intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms
> Cardiac Fusion: which is intended to analyze cardiac anatomy and pathology with a fused image of functional data (e.g. NM image, Bulls eye) and anatomical data
> Aortic Valve Analysis for contrast CT heart images: which is intended for visualization of the heart, aorta regions, and contour of the aorta, measurement of the vicinity of the aortic valve, measurement of the calcification area in the aorta.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130383 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130383: Synapse 3D Cardiac Tools.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130383
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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