510(k) · Cleared
ClearedSynapse 3D Optional Tools
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Corporation · LLZ System, Image Processing, Radiological
Cleared on Sep 25, 2018 as substantially equivalent to K120361 (Fujifilm Medical Systems U.S.A, Inc., 2012) after an 84-day review. Its family tree reaches back 9 generations to 1991.
- Decided
- Sep 25, 2018
- Review
- 84 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K913770 (1991). 40 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- 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 deviceK181773 Synapse 3D Optional ToolsFujifilm Corporation · 2018
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 deviceK181773 Synapse 3D Optional ToolsFujifilm Corporation · 2018
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) | K181773 | Synapse 3D Optional Tools | Fujifilm Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K120361 | Synapse 3D Base ToolsSummary page 4…21 CFR 892.2050 Device Class: Class II Panel: Radiology Primary Predicate Devices: Synapse 3D Base Tools (K120361), FUJIFILM Medical Systems U.S.A., Inc. Reference Predicate Devices: REXTM (K021099), PointDx, Inc.… | 2012 |
| † | K021099 | Rex, Version 1.0 | 2002 |
| † | K152602 | Olea Sphere V3.0 | 2016 |
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 27 years and passes through 9 companies; a new generation was cleared every 1.8 years on median.
- 7 of the 40 ancestors have a recall of any class.
- 3 other devices also cite its predicate K120361.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Optional Tools 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 Optional Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including CT, MR. This product is not intended for use with or for the primary diagnostic interpretation of Mammography…
Read the full statement (110 words)
Synapse 3D Optional Tools 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 Optional Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including CT, MR. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. Addition to the tools in Synapse 3D Base Tools, Synapse 3D Optional Tools provides:
* Imaging tools for CT images including virtual endoscopic viewing.
* Imaging tools for MR images including delayed enhancement image viewing and diffusion-weighted MRI data analysis.
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/K181773 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181773: Synapse 3D Optional Tools.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181773
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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