510(k) · Cleared
ClearedSynapse 3D Tensor Analysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Meidcal Systems U.S.A.,Inc. · LLZ System, Image Processing, Radiological
Cleared on Sep 3, 2014 as substantially equivalent to K113701 (MeVis Medical Solutions AG, 2012) and 2 other predicates after an 86-day review. Its family tree reaches back 9 generations to 1991. 3 of the 55 devices in its family, counting itself, have a Class I recall.
- Decided
- Sep 3, 2014
- Review
- 86 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K913770 (1991). 54 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet. 3 of the 55 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations between
- 3 generations backK061214 Aquariusaps ServerTerarecon,Inc. · 2006
- 2 generations backK101662 Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc. · 2010
- 1 generation backK120361 Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc. · 2012
- This deviceK141514 Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014
Show all 9 generations
- Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 7 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 6 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 5 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 4 generations backK041807 Lung Car 1.1Medicsight · 2004
- 3 generations backK061214 Aquariusaps ServerTerarecon,Inc. · 2006
- 2 generations backK101662 Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc. · 2010
- 1 generation backK120361 Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc. · 2012
- This deviceK141514 Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −8 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −7 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −6 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −5 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −4 | K041807 | Lung Car 1.1 | Medicsight | 2004 | — |
| −3 | K061214 | Aquariusaps Server | Terarecon,Inc. | 2006 | — |
| −2 | K101662 | Synapse 3D Basic Tools | Fujifilm Medical System U.S.A., Inc. | 2010 | — |
| −1 | K120361 | Synapse 3D Base Tools | Fujifilm Medical Systems U.S.A, Inc. | 2012 | — |
| 0 (this device) | K141514 | Synapse 3D Tensor Analysis | Fujifilm Meidcal Systems U.S.A.,Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 1 |
| 2005 | 2 | 2 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 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.
3 devices in this family have 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? (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 |
|---|---|---|---|
| * | K113701 | Visia NeuroSummary page 5…es, white matter tractography, dynamic review in MR, vessel and body visualization with registration of MR, CT, XA, PET and NM. Predicate Devices: VisiaTM Neuro (K113701), MeVis Medical Solutions AG Synapse 3D Base Tools (K120361), FUJIFILM Medical Systems U.S.A., Inc. Ready View (K113456… | 2012 |
| * | K120361 | Synapse 3D Base ToolsSummary page 5…se 3D Tensor Analysis Description of the Device Synapse 3D Tensor Analysis is an optional software module that works with Synapse 3D Base Tools, cleared by CDRH via K120361 on 04/06/2012. Synapse 3D Tensor Analysis, Synapse 3D Base Tools and other optional software modules consist of the Synapse 3D… | 2012 |
| * | K113456 | Ready ViewSummary page 5…Predicate Devices: VisiaTM Neuro (K113701), MeVis Medical Solutions AG Synapse 3D Base Tools (K120361), FUJIFILM Medical Systems U.S.A., Inc. Ready View (K113456), GE Healthcare 05 - 2 MEDICAL SYSTEMS U.S.A.,… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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.
- K052078Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · 3 generations back · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
- K043147Achieva FamilyPhilips Medical Systems North America Co. · 2005 · 4 generations back · ◆ in the 2005 ancestors bar of FIG. 13 Class I recalls
- K041602Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · 4 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 9 companies; a new generation was cleared every 1.8 years on median.
- 13 of the 54 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Tensor Analysis is medical imaging software used with Synapse 3D Base Tools to accept, display, and process DICOM compliant 2D and 3D medical images acquired from MR for the purpose of viewing of local water diffusion properties and directional dependence of the diffusion in the white matter. It is intended to be used by trained medical professionals in reading, interpreting, reporting, screening and treatment planning. Addition to the general…
Read the full statement (135 words)
Synapse 3D Tensor Analysis is medical imaging software used with Synapse 3D Base Tools to accept, display, and process DICOM compliant 2D and 3D medical images acquired from MR for the purpose of viewing of local water diffusion properties and directional dependence of the diffusion in the white matter. It is intended to be used by trained medical professionals in reading, interpreting, reporting, screening and treatment planning.
Addition to the general 2D and 3D image processing and measurement tools available in Synapse 3D Base Tools, Synapse 3D Tensor Analysis provides custom workflows, UI, and reporting functions for tensor analysis with neck and head MR images. It includes display of diffusion and FA color map images, white matter tractography, dynamic review in MR, vessel and body visualization with registration of MR, CT, XA, PET and NM.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141514: Synapse 3D Tensor Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141514
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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