510(k) · Cleared
ClearedSynapse 3D Base Tools (V7.2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Corporation · QIH Automated Radiological Image Processing Software
Cleared on Apr 30, 2026 as substantially equivalent to K243762 (Fujifilm Corporation, 2025) after a 128-day review. Its family tree reaches back 12 generations to 1991.
- Decided
- Apr 30, 2026
- Review
- 128 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K913770 (1991). 43 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations between
- 3 generations backK203103 Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation · 2021
- 2 generations backK221677 Synapse 3D Base Tools v6.6Fujifilm Corporation · 2022
- 1 generation backK243762 Synapse 3D Base Tools (V7.0)Fujifilm Corporation · 2025
- This deviceK254189 Synapse 3D Base Tools (V7.2)Fujifilm Corporation · 2026
Show all 12 generations
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 11 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 10 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 9 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 8 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 7 generations backK041807 Lung Car 1.1Medicsight · 2004
- 6 generations backK061214 Aquariusaps ServerTerarecon,Inc. · 2006
- 5 generations backK101662 Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc. · 2010
- 4 generations backK120361 Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc. · 2012
- 3 generations backK203103 Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation · 2021
- 2 generations backK221677 Synapse 3D Base Tools v6.6Fujifilm Corporation · 2022
- 1 generation backK243762 Synapse 3D Base Tools (V7.0)Fujifilm Corporation · 2025
- This deviceK254189 Synapse 3D Base Tools (V7.2)Fujifilm Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −11 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −10 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −9 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −8 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −7 | K041807 | Lung Car 1.1 | Medicsight | 2004 | — |
| −6 | K061214 | Aquariusaps Server | Terarecon,Inc. | 2006 | — |
| −5 | K101662 | Synapse 3D Basic Tools | Fujifilm Medical System U.S.A., Inc. | 2010 | — |
| −4 | K120361 | Synapse 3D Base Tools | Fujifilm Medical Systems U.S.A, Inc. | 2012 | — |
| −3 | K203103 | Synapse 3D, Synapse 3D Base Tools v6.1 | Fujifilm Corporation | 2021 | — |
| −2 | K221677 | Synapse 3D Base Tools v6.6 | Fujifilm Corporation | 2022 | — |
| −1 | K243762 | Synapse 3D Base Tools (V7.0) | Fujifilm Corporation | 2025 | — |
| 0 (this device) | 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 |
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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 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 |
|---|---|---|---|
| * | K243762 | Synapse 3D Base Tools (V7.0)Summary page 6…ation Number: 21 CFR 892.2050 Device Class: Class II Panel: Radiology Predicate Devices: Synapse 3D Base Tools (V7.0) (K243762) FUJIFILM Corporation 510(k) Summary… | 2025 |
| † | K170981 | NeuroQuant | 2017 |
| † | K200973 | Synapse 3D Cardiac Tools | 2020 |
| † | K191544 | Synapse 3D Blood Flow Analysis | 2019 |
| † | K130542 | Synapse 3D Lung and Abdomen Analysis | 2013 |
| † | K142521 | Synapse 3D Liver and Kidney Analysis | 2014 |
| † | K141514 | Synapse 3D Tensor Analysis | 2014 |
| † | K162287 | Synapse 3D Perfusion Analysis | 2017 |
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 35 years and passes through 9 companies; a new generation was cleared every 1.8 years on median.
- 7 of the 43 ancestors have a recall of any class.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
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. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. Synapse 3D…
Read the full statement (429 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.
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 Intensity Projection (MIP), Average Intensity Projection (RaySum) and Minimum Intensity Projection (MinIP), 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.
- Regional segmentation tools for anatomical structures within image data, including path definition through vascular and other tubular structures and boundary detection.
- Modality-specific image viewing tools, including fusion and ADC image viewing for MR studies.
- General imaging tools for CT images, including virtual endoscopic viewing, dual energy image viewing, and segmentation of ROI based on user-specified locations.
- General imaging tools for MR images, including diffusion-weighted MRI viewing.
- Cardiac analysis for MR heart images, including delayed enhancement image viewing, functional characteristics viewing, and calcium scoring.
- Blood flow analysis for multi-phase and velocity-encoded MR images, including blood flow velocity and direction analysis.
- Lung analysis for non-contrast and contrast-enhanced CT images, including boundary detection and volume calculation for pulmonary nodules based on user-specified locations, segmentation of bronchial tubes, approximation of air supply regions by user-defined bronchial tubes, identification and processing of low absorption regions, analysis of bronchial pathways to reach lung nodules using CT volume data, and simulation of bronchoscope insertion along the path.
- Liver analysis for contrast-enhanced CT images, including liver and peripheral organ segmentation, tumor segmentation based on user-specified locations, segmentation of intrahepatic and peripheral vessels, and approximation of vascular territories.
- Tensor analysis for neck and head MR images, including diffusion and FA color maps, white matter tractography, dynamic MR review, and vessel and body visualization with registration of MR, CT, XA, PET, and NM.
- Perfusion analysis for dynamically scanned cerebral CT arteriography, including parameters such as blood volume (BV), blood flow (BF), mean transit time (MTT), and time to peak (TTP).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254189 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254189: Synapse 3D Base Tools (V7.2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254189
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026