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 Jul 5, 2012 as substantially equivalent to K103465 (Fujifilm Medical Systems U.S.A, Inc., 2011) and 1 other predicate after a 126-day review. Its family tree reaches back 11 generations to 1991. 19 later devices descend from it.
- Decided
- Jul 5, 2012
- Review
- 126 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K913770 (1991). 61 ancestors in all, the oldest K871859 (1987). 19 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations between
- 3 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 2 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 1 generation backK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
- This deviceK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
- Descendant · cites it directly · 12 of its ownK171222 Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017
- Descendant · 2 generations on · 11 of its ownK173088 Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018
- Descendant · 2 generations on · 9 of its ownK183013 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018
- Descendant · 3 generations on · 8 of its ownK192923 Vitrea Software PackageCanon Medical Systems Corporation · 2020
- Descendant · 4 generations on · 7 of its ownK203312 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2021
Show all 11 generations
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 9 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 8 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 7 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 6 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 5 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 4 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 3 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 2 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 1 generation backK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
- This deviceK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017 · cites it directly12descendants
- K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018 · 2 generations on11descendants
- K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018 · 2 generations on9descendants
- K192923Vitrea Software PackageCanon Medical Systems Corporation · 2020 · 3 generations on8descendants
- K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2021 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −10 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −9 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −8 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −7 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −6 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −5 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −4 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −3 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −2 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| −1 | K073156 | Qplaque MR | Medis Medical Imaging Systems BV | 2008 | — |
| 0 (this device) | K120636 | Synapse 3D Cardiac Tools | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| +1 | K171222 | Vitrea Software Toshiba Package; VSTP-001A | Toshibamedical Systems Corporation | 2017 | — |
| +2 | K173088 | Vitrea Software Toshiba Package VSTP-001A | Toshibamedical Systems Corporation | 2018 | — |
| +2 | K183013 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2018 | — |
| +3 | K192923 | Vitrea Software Package | Canon Medical Systems Corporation | 2020 | — |
| +4 | K203312 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2021 | — |
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 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K103465 | Synapse 3D Cardiac ToolsSummary page 2…3C FWIFILM Medical Systems U.S.A., Inc. Synapse 3D Cardiac Tools (V3.0) 510O(k) Predicate Device: * Synapse 3D Cardiac Tools, FWIFILM Medical Systems U.S.A., Inc. (K103465) * QPlaque MR, Medis Medical Imaging Systems, By. (K073156) Description of the Device Synapse 3D Cardiac Tools (V3.0) isthe… | 2011 |
| * | K073156 | Qplaque MRSummary page 2…s (V3.0) 510O(k) Predicate Device: * Synapse 3D Cardiac Tools, FWIFILM Medical Systems U.S.A., Inc. (K103465) * QPlaque MR, Medis Medical Imaging Systems, By. (K073156) Description of the Device Synapse 3D Cardiac Tools (V3.0) isthe updated version of previously-cleared Synapse 3D Cardiac Tools… | 2008 |
What descends from it? (19)
See all 192 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 21 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 10 of the 61 ancestors have a recall of any class.
- Of its descendants, K171222 (Toshibamedical Systems Corporation, 2017) has gone furthest, with 12 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. 2012, 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 then in reading, interpreting, reporting, and treatment planning. Synapse 3D Cardiac Tools accepts DICOM compliant medical images acqired from a variety of imaging devices including, CT, MR, NM, and XA. This product is not intended for use with or for the primary diagnostic interpretation of…
Read the full statement (245 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 then in reading, interpreting, reporting, and treatment planning. Synapse 3D Cardiac Tools accepts DICOM compliant medical images acqired from a variety of imaging devices including, CT, MR, NM, and XA.
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images..
Addition to the tools i Synapse 3D Base Tools, Synapse 3D Cardiac Tools provides the tools for specific clinical applications which provide targeted workflowvs, custom UI, targeted measurements and reporting functions including:
> Functional cardiac analysis for CT left ventriailography 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120636 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120636: Synapse 3D Cardiac Tools.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120636
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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