510(k) · Cleared
ClearedSynapse 3D Lung and Abdomen Analysis
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 Jun 14, 2013 as substantially equivalent to K120648 (Fujifilm Medical System U.S.A., Inc., 2012) and 1 other predicate after a 105-day review. Its family tree reaches back 8 generations to 1995. 9 later devices descend from it.
- Decided
- Jun 14, 2013
- Review
- 105 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K954355 (1995). 12 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 7 generations backK974715 Advantage 3D XRGE Medical Systems · 1998
- 6 generations backK984634 3D-AngioSiemens Medical Corp. · 1999
- 5 generations backK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
- 4 generations backK043469 Syngo Inspace 4DSiemens AG Medical Solutions · 2005
- 3 generations backK071513 Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007
- 2 generations backK083227 Vida Pulmonary Workstation 2 (PW2)Vida Diagnostics, Inc. · 2008
- 1 generation backK120648 Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc. · 2012
- This deviceK130542 Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc. · 2013
- 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 · cites it directly · 1 of its ownK223556 DeepCatchMedical IP Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK181892 Ziostation2Ziosoft, Inc. · 2018
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · 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
- K223556DeepCatchMedical IP Co., Ltd. · 2023 · cites it directly1descendant
- K181892Ziostation2Ziosoft, Inc. · 2018 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| −7 | K974715 | Advantage 3D XR | GE Medical Systems | 1998 | — |
| −6 | K984634 | 3D-Angio | Siemens Medical Corp. | 1999 | — |
| −5 | K011447 | IN Space 3D | Siemens Medical Solutions USA, Inc. | 2001 | — |
| −4 | K043469 | Syngo Inspace 4D | Siemens AG Medical Solutions | 2005 | — |
| −3 | K071513 | Inspace 4D Software Package with Extended Functionality | Siemens Medical Solutions | 2007 | — |
| −2 | K083227 | Vida Pulmonary Workstation 2 (PW2) | Vida Diagnostics, Inc. | 2008 | — |
| −1 | K120648 | Synapse 3D Lung and Abdomen Analysis | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| 0 (this device) | K130542 | Synapse 3D Lung and Abdomen Analysis | Fujifilm Medical System U.S.A., Inc. | 2013 | — |
| +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 | — |
| +1 | K223556 | DeepCatch | Medical IP Co., Ltd. | 2023 | — |
| +1 | K181892 | Ziostation2 | Ziosoft, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
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 |
|---|---|---|---|
| * | K120648 | Synapse 3D Lung and Abdomen AnalysisSummary page 2…1361 FUJIFILM Medical Systems U.S.A., Inc. Synapse 3D Lung and Abdomen Analysis (V3.2) 510(k) Predicate Device: » Synapse 3D Lung and Abdomen Analysis (K120648), FUJIFILM Medical Systems U.S.A., Inc. » Pulmonary Workstation 2 (K083227), VIDA Diagnostics, Inc. Description of the Device Sy… | 2012 |
| * | K083227 | Vida Pulmonary Workstation 2 (PW2)Summary page 2…and Abdomen Analysis (V3.2) 510(k) Predicate Device: » Synapse 3D Lung and Abdomen Analysis (K120648), FUJIFILM Medical Systems U.S.A., Inc. » Pulmonary Workstation 2 (K083227), VIDA Diagnostics, Inc. Description of the Device Synapse 3D Lung and Abdomen Analysis is the updated version of previously -cl… | 2008 |
What descends from it? (9)
3 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 18 years and passes through 8 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K151988 (Visible Patient, Sas, 2015) has gone furthest, with 4 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. 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 Lung and Abdomen Analysis 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 Lung and Abdomen Analysis accepts DICOM compliant medical images acquired from CT. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. Addition to…
Read the full statement (198 words)
Synapse 3D Lung and Abdomen Analysis 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 Lung and Abdomen Analysis accepts DICOM compliant medical images acquired from CT.
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 Lung and Abdomen Analysis is intended to;
- use non-contrast and contrast enhanced computed tomographic images of the lung, provide custom workflows and Ul, and reporting functions for lung analysis including boundary detection and volume calculation for pulmonary nodules in the lung based on the location specified by the user, segmentation of bronchial tubes in the lung. approximation of air supply region by the user specified bronchial tube, identifying, displaying and processing low absorption regions in the lung.
- use non-contrasted CT images and calculate subcutaneous fat and visceral fat areas in 2D and both volumes in 3D.
- analyze a bronchus path to reach a lung nodule using the volume data collected with CT, and simulate insertion of bronchoscope into the path.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130542: Synapse 3D Lung and Abdomen Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130542
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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