510(k) · Cleared
ClearedSynapse 3D Basic Tools
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 Jul 26, 2010 as substantially equivalent to K070831 (Barcoview Mis Edinburgh, 2007) and 1 other predicate after a 42-day review. Its family tree reaches back 7 generations to 1991. 14 later devices descend from it.
- Decided
- Jul 26, 2010
- Review
- 42 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K913770 (1991). 31 ancestors in all. 14 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 5 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 4 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 3 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 2 generations backK041807 Lung Car 1.1Medicsight · 2004
- 1 generation backK061214 Aquariusaps ServerTerarecon,Inc. · 2006
- This deviceK101662 Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc. · 2010
- Descendant · cites it directly · 13 of its ownK120361 Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc. · 2012
- Descendant · 2 generations on · 5 of its ownK203103 Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation · 2021
- Descendant · 3 generations on · 4 of its ownK221677 Synapse 3D Base Tools v6.6Fujifilm Corporation · 2022
- Descendant · 2 generations on · 4 of its ownK151988 Visible Patient SuiteVisible Patient, Sas · 2015
- Descendant · 3 generations on · 3 of its ownK212896 Visible Patient SuiteVisible Patient, Sas · 2021
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K120361Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc. · 2012 · cites it directly13descendants
- K203103Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation · 2021 · 2 generations on5descendants
- K221677Synapse 3D Base Tools v6.6Fujifilm Corporation · 2022 · 3 generations on4descendants
- K151988Visible Patient SuiteVisible Patient, Sas · 2015 · 2 generations on4descendants
- K212896Visible Patient SuiteVisible Patient, Sas · 2021 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −6 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −5 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −4 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −3 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −2 | K041807 | Lung Car 1.1 | Medicsight | 2004 | — |
| −1 | K061214 | Aquariusaps Server | Terarecon,Inc. | 2006 | — |
| 0 (this device) | 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 | — |
| +2 | K203103 | Synapse 3D, Synapse 3D Base Tools v6.1 | Fujifilm Corporation | 2021 | — |
| +3 | K221677 | Synapse 3D Base Tools v6.6 | Fujifilm Corporation | 2022 | — |
| +2 | K151988 | Visible Patient Suite | Visible Patient, Sas | 2015 | — |
| +3 | K212896 | Visible Patient Suite | Visible Patient, Sas | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K070831 | Voxar 3D Enterprise with Colonmetrix and Pet/CT PerfusionSummary page 2…se 3D Basic Tools 510O(k) Decision Date: TBD Decision: TBD Predicate Devices: * Voxar 3D Enterprise with ColonMetrix and PET/CT Perfusion (Voxar) 510O(k) #: K07083 1, cleared by CDRH on May 22, 2007. * Aquarius APS Server (iNtuition) (TeraRecon) 510O(k) #: K061214, cleared by CDRH on May… | 2007 |
| * | K061214 | Aquariusaps ServerSummary page 2…e with ColonMetrix and PET/CT Perfusion (Voxar) 510O(k) #: K07083 1, cleared by CDRH on May 22, 2007. * Aquarius APS Server (iNtuition) (TeraRecon) 510O(k) #: K061214, cleared by CDRH on May 15, 2006 Description of the Device The Synapse 3D Basic Tools software offers software tools which can b… | 2006 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120361 | Synapse 3D Base Tools | 2012 | 13 |
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 19 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 31 ancestors have a recall of any class.
- Of its descendants, K120361 (Fujifilm Medical Systems U.S.A, Inc., 2012) has gone furthest, with 13 descendants of its own.
- 7 other devices also cite its predicate K070831.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The Synapse 3D Basic Tools Software is medical imaging software 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. The Synapse 3D Basic Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including, CT, MR, CR, US, NM, PT, and XA, etc. This product is not intended for use with or…
Read the full statement (189 words)
The Synapse 3D Basic Tools Software is medical imaging software 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. The Synapse 3D Basic Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including, CT, MR, CR, US, NM, PT, and XA, etc.
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
The Synapse 30 Basic Tools Software provides several levels of tools to the user:
> Basic imaging tools for general images, such as 20 viewing, volume rendering and 30 volume viewing, orthogonal I oblique I curved Multi-Planar Reconstructions (MPR), Maximum (MIP), Average (RaySum) and Minimum (MinIP) Intensity Projection, 40 volume viewing, image fusion, image subtraction, CT PET fusion, surface rendering, sector and rectangular shape MPR image viewing, time-density distribution, basic image processing, CINE, measurements, annotations, reporting, printing, storing, distribution, and general image management and administration tools, etc.
> Tools for regional segmentation of anatomical structures within the image data, path definition through vascular and other tubular structures, and boundary detection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101662 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101662: Synapse 3D Basic Tools.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101662
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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