510(k) · Cleared
ClearedSynapse 3D Liver and Kidney 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 Dec 1, 2014 as substantially equivalent to K121213 (Vital Images, Inc., 2012) and 1 other predicate after an 84-day review. Its family tree reaches back 12 generations to 1991. 5 later devices descend from it.
- Decided
- Dec 1, 2014
- Review
- 84 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K913770 (1991). 103 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 backK072821 Vitrea 4DCTVital Images, Inc. · 2008 · Recalled
- 1 generation backK121213 VitreaadvancedVital Images, Inc. · 2012 · Recalled
- This deviceK142521 Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014
- Descendant · cites it directly · 4 of its ownK151988 Visible Patient SuiteVisible Patient, Sas · 2015
- Descendant · 2 generations on · 3 of its ownK212896 Visible Patient SuiteVisible Patient, Sas · 2021
- Descendant · 3 generations on · 1 of its ownK250237 InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2025
- Descendant · 4 generations on · 0 of its ownK260973 InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK233457 RUSHutom, Inc. · 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 backK072821 Vitrea 4DCTVital Images, Inc. · 2008 · Recalled
- 1 generation backK121213 VitreaadvancedVital Images, Inc. · 2012 · Recalled
- This deviceK142521 Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014
Most influential descendants
Showing 5 of 5 · See all- K151988Visible Patient SuiteVisible Patient, Sas · 2015 · cites it directly4descendants
- K212896Visible Patient SuiteVisible Patient, Sas · 2021 · 2 generations on3descendants
- K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2025 · 3 generations on1descendant
- K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2026 · 4 generations on0descendants
- K233457RUSHutom, Inc. · 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 | K072821 | Vitrea 4DCT | Vital Images, Inc. | 2008 | 1 |
| −1 | K121213 | Vitreaadvanced | Vital Images, Inc. | 2012 | 1 |
| 0 (this device) | K142521 | Synapse 3D Liver and Kidney Analysis | Fujifilm Meidcal Systems U.S.A.,Inc. | 2014 | — |
| +1 | K151988 | Visible Patient Suite | Visible Patient, Sas | 2015 | — |
| +2 | K212896 | Visible Patient Suite | Visible Patient, Sas | 2021 | — |
| +3 | K250237 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2025 | — |
| +4 | K260973 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2026 | — |
| +3 | K233457 | RUS | Hutom, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 6 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 12 | 0 |
| 2002 | 9 | 0 |
| 2003 | 7 | 0 |
| 2004 | 8 | 0 |
| 2005 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (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 |
|---|---|---|---|
| * | K121213 | VitreaadvancedSummary page 6…ssels as well as the approximation of vascular territories is provided using contrst enhanced computed tomographic images. Predicate Devices: VitreaAdvanced (K121213), Vital Images, Inc. IQQA-Liver Multimodality software (K131498), EDDA Technology Technological Characteristics The… | 2012 |
| * | K131498 | Iqqa-Liver Multimodality SoftwareSummary page 6…ing contrst enhanced computed tomographic images. Predicate Devices: VitreaAdvanced (K121213), Vital Images, Inc. IQQA-Liver Multimodality software (K131498), EDDA Technology Technological Characteristics The proposed Synapse 3D Liver and Kidney Analysis and the predicate devices,… | 2013 |
| † | K110186 | Synapse 3D Liver Analysis | 2011 |
| † | K120361 | Synapse 3D Base Tools | 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 |
|---|---|---|---|
| K151988 | Visible Patient Suite | 2015 | 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 23 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 29 of the 103 ancestors have a recall of any class.
- Of its descendants, K151988 (Visible Patient, Sas, 2015) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K121213.
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 Liver and Kidney Analysis is medical imaging software used with Synapse 3D Base 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 Liver and Kidney Analysis accepts DICOM compliant medical images. This product is not intended for use with or for the primary diagnostic interpretation of…
Read the full statement (134 words)
Synapse 3D Liver and Kidney Analysis is medical imaging software used with Synapse 3D Base 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 Liver and Kidney Analysis accepts DICOM compliant medical images. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
Addition to Synapse 3D Base Tools, Synapse 3D Liver and Kidney Analysis uses contrast enhanced images of the body and provides custom workflows and UI, and reporting functions for liver and kidney analysis including, liver and peripheral organ segmentation, and tumor segmentation. Also segmentation of intrahepatic and peripheral vessels as well as the approximation of vascular territories is provided using contrast enhanced computed tomographic images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142521: Synapse 3D Liver and Kidney Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142521
Report an extraction error
Are you the manufacturer?
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