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 Systems U.S.A, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jan 31, 2011 as substantially equivalent to K061326 (Barcoview Mis Edinburgh, 2006) and 2 other predicates after a 68-day review. Its family tree reaches back 6 generations to 1996. 20 later devices descend from it.
- Decided
- Jan 31, 2011
- Review
- 68 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K954874 (1996). 25 ancestors in all, the oldest K871859 (1987). 20 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 5 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 4 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 3 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 2 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 1 generation backK061370 Cardiq FusionGE Healthcare · 2006
- This deviceK103465 Synapse 3D Cardiac ToolsFujifilm Medical Systems U.S.A, Inc. · 2011
- Descendant · cites it directly · 19 of its ownK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
- Descendant · 2 generations on · 12 of its ownK171222 Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017
- Descendant · 3 generations on · 11 of its ownK173088 Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018
- Descendant · 3 generations on · 9 of its ownK183013 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018
- Descendant · 4 generations on · 8 of its ownK192923 Vitrea Software PackageCanon Medical Systems Corporation · 2020
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012 · cites it directly19descendants
- K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017 · 2 generations on12descendants
- K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018 · 3 generations on11descendants
- K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018 · 3 generations on9descendants
- K192923Vitrea Software PackageCanon Medical Systems Corporation · 2020 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −5 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −4 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −3 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −2 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −1 | K061370 | Cardiq Fusion | GE Healthcare | 2006 | — |
| 0 (this device) | K103465 | Synapse 3D Cardiac Tools | Fujifilm Medical Systems U.S.A, Inc. | 2011 | — |
| +1 | K120636 | Synapse 3D Cardiac Tools | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| +2 | K171222 | Vitrea Software Toshiba Package; VSTP-001A | Toshibamedical Systems Corporation | 2017 | — |
| +3 | K173088 | Vitrea Software Toshiba Package VSTP-001A | Toshibamedical Systems Corporation | 2018 | — |
| +3 | K183013 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2018 | — |
| +4 | K192923 | Vitrea Software Package | Canon Medical Systems Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 3 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K061326 | Voxar 3D Enterprise with CardiametrixSummary page 2…Synapse 3D Cardiac Tools Page 21 of 11101 Decision Date: TBD Decision: TBID Predicate Devices: *Voxar 3D Enterprise with CardiaMetrix, K061326 *71 Soft MR Cardiac Function Analysis, K091262 *GE CardIQ Fusion, K061370 Description of the Device Synapse 3D Cardiac To… | 2006 |
| * | K091262 | MR Cardiac Function AnalysisSummary page 2…101 Decision Date: TBD Decision: TBID Predicate Devices: *Voxar 3D Enterprise with CardiaMetrix, K061326 *71 Soft MR Cardiac Function Analysis, K091262 *GE CardIQ Fusion, K061370 Description of the Device Synapse 3D Cardiac Tools is with Fujifilm's Synapse 3D Basic Tools (K10… | 2009 |
| * | K061370 | Cardiq FusionSummary page 2…ate: TBD Decision: TBID Predicate Devices: *Voxar 3D Enterprise with CardiaMetrix, K061326 *71 Soft MR Cardiac Function Analysis, K091262 *GE CardIQ Fusion, K061370 Description of the Device Synapse 3D Cardiac Tools is with Fujifilm's Synapse 3D Basic Tools (K101662, cleared by CDRH on July… | 2006 |
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120636 | Synapse 3D Cardiac Tools | 2012 | 19 |
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 15 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 25 ancestors have a recall of any class.
- Of its descendants, K120636 (Fujifilm Medical System U.S.A., Inc., 2012) has gone furthest, with 19 descendants of its own.
- 1 other device also cites its predicate K061326.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Basic Tools that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, 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, NM, and XA. This product is not intended for use with or…
Read the full statement (230 words)
Synapse 3D Cardiac Tools is medical imaging software used with Synapse 3D Basic Tools that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, 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, NM, and XA.
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
Addition to the tools with Synapse 3D Basic 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 contrasted 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
>Calcium scoring for non contrasted 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/K103465 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103465: 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/K103465
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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