510(k) · Cleared
ClearedSynapse 3D Nodule Analysis
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 Jun 1, 2012 as substantially equivalent to K042694 (GE Medical Systems, 2004) after an 87-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Jun 1, 2012
- Review
- 87 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K913770 (1991). No later device cites it as a predicate yet.
- Root · 6 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 4 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 3 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 2 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 1 generation backK042694 Advanced Lung Analysis IIGE Medical Systems · 2004
- This deviceK120679 Synapse 3D Nodule AnalysisFujifilm Medical Systems U.S.A, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −5 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −4 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −3 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −2 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −1 | K042694 | Advanced Lung Analysis II | GE Medical Systems | 2004 | — |
| 0 (this device) | K120679 | Synapse 3D Nodule Analysis | Fujifilm Medical Systems U.S.A, Inc. | 2012 | — |
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? (1)
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 |
|---|---|---|---|
| * | K042694 | Advanced Lung Analysis IISummary page 2…2 === FUJIFILM Medical Systems U.S.A., Inc. Synapse 3D Nodule Analysis 510O(k) Predicate Device: *Advantage Windows Lung Analysis: GE Healthcare (GE Medical Systems) (K042694). Description of the Device Synapse 3D Nodule Analysis is an optional software module that works with Synapse 3D Base Tools (… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 companies; a new generation was cleared every 4.8 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K042694.
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 Nodule 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 Nodule Analysis accepts DICOM compliant medical images acquired from CT and PT. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. Addition to Synapse 3D Base…
Read the full statement (183 words)
Synapse 3D Nodule 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 Nodule Analysis accepts DICOM compliant medical images acquired from CT and PT.
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 Nodule Analysis is intended to;
" use non-contrast and contrast enhanced computed tomography (CT) images, provie custom workflows and UI, and reporting functions for nodule analysis including boundary detection of nodules based on the location specified by the user, measurement of nodules, temporal comparison of nodule images, and fusion of a CT nodule image on a PT nodule image.
> use positron emission tomography (PT) images, provide wustom workflows and UI, and reporting functions for nodule analysis including SLWV measurement of nodules with sphere VOl based on the location specified by the user, temporal comparison of nodule images, and fuision of a PT nodule image on a CT nodule image.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120679 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120679: Synapse 3D Nodule Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120679
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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