510(k) · Cleared
ClearedSynapse 3D Base Tools v6.6
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 Nov 10, 2022 as substantially equivalent to K203103 (Fujifilm Corporation, 2021) after a 154-day review. Its family tree reaches back 10 generations to 1991. 4 later devices descend from it.
- Decided
- Nov 10, 2022
- Review
- 154 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K913770 (1991). 41 ancestors in all, the oldest K871859 (1987). 4 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations between
- 3 generations backK101662 Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc. · 2010
- 2 generations backK120361 Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc. · 2012
- 1 generation backK203103 Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation · 2021
- This deviceK221677 Synapse 3D Base Tools v6.6Fujifilm Corporation · 2022
- Descendant · cites it directly · 1 of its ownK243647 Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation · 2025
- Descendant · cites it directly · 1 of its ownK243762 Synapse 3D Base Tools (V7.0)Fujifilm Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK261713 Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK254189 Synapse 3D Base Tools (V7.2)Fujifilm Corporation · 2026
Show all 10 generations
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 8 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 7 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 6 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 5 generations backK041807 Lung Car 1.1Medicsight · 2004
- 4 generations backK061214 Aquariusaps ServerTerarecon,Inc. · 2006
- 3 generations backK101662 Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc. · 2010
- 2 generations backK120361 Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc. · 2012
- 1 generation backK203103 Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation · 2021
- This deviceK221677 Synapse 3D Base Tools v6.6Fujifilm Corporation · 2022
Most influential descendants
Showing 4 of 4 · See all- K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation · 2025 · cites it directly1descendant
- K243762Synapse 3D Base Tools (V7.0)Fujifilm Corporation · 2025 · cites it directly1descendant
- K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation · 2026 · 2 generations on0descendants
- K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −9 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −8 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −7 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −6 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −5 | K041807 | Lung Car 1.1 | Medicsight | 2004 | — |
| −4 | K061214 | Aquariusaps Server | Terarecon,Inc. | 2006 | — |
| −3 | K101662 | Synapse 3D Basic Tools | Fujifilm Medical System U.S.A., Inc. | 2010 | — |
| −2 | K120361 | Synapse 3D Base Tools | Fujifilm Medical Systems U.S.A, Inc. | 2012 | — |
| −1 | K203103 | Synapse 3D, Synapse 3D Base Tools v6.1 | Fujifilm Corporation | 2021 | — |
| 0 (this device) | K221677 | Synapse 3D Base Tools v6.6 | Fujifilm Corporation | 2022 | — |
| +1 | K243647 | Synapse PACS (7.5) | FUJIFILM Healthcare Americas Corporation | 2025 | — |
| +1 | K243762 | Synapse 3D Base Tools (V7.0) | Fujifilm Corporation | 2025 | — |
| +2 | K261713 | Synapse PACS (7.6.0) | FUJIFILM Healthcare Americas Corporation | 2026 | — |
| +2 | K254189 | Synapse 3D Base Tools (V7.2) | Fujifilm Corporation | 2026 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K203103 | Synapse 3D, Synapse 3D Base Tools v6.1Summary page 4…Number: 21 CFR 892.2050 Device Class: Class II Panel: Radiology Predicate Devices: Synapse 3D Base Tools (K203103) FUJIFILM Corporation Reference Devices syngo.CT Dual Energy (K133648)… | 2021 |
| † | K133648 | Syngo, CT Dual Energy | 2014 |
| † | K161625 | PixelShine | 2016 |
What descends from it? (4)
2 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 31 years and passes through 9 companies; a new generation was cleared every 1.8 years on median.
- 7 of the 41 ancestors have a recall of any class.
- Of its descendants, K243647 (FUJIFILM Healthcare Americas Corporation, 2025) has gone furthest, with 1 descendant 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. 2022, 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 Base Tools is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Base 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.…
Read the full statement (231 words)
Synapse 3D Base Tools is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Base 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.
Synapse 3D Base Tools provides several levels of tools to the user:
Basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, orthogonal/oblique/ curved Multi-Planar Reconstructions (MPR), Maximum (MIP), Average (RaySum) and Minimum (MinIP) Intensity Projection, 4D volume viewing, image fusion, image subtraction, surface rendering, sector and rectangular shape MPR image viewing, MPR for dental images, creating and displaying multiple MPR images along an object, time-density distribution, basic image processing, noise reduction, 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.
-Image viewing tools for modality specific images, including CT PET fusion and ADC image viewing for MR studies.
-Imaging tools for CT images including virtual endoscopic viewing and dual energy image viewing.
-Imaging tools for MR images including delayed enhancement image viewing, diffusion-weighted MRI image viewing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221677 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221677: Synapse 3D Base Tools v6.6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221677
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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