# K254189: Synapse 3D Base Tools (V7.2)

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: Apr 30, 2026 after 128 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K913770 (1991). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243762: Synapse 3D Base Tools (V7.0), Fujifilm Corporation (2025) Summary page 6.

## Indications for use
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).

Source page: https://510kreport.com/device/K254189
Methodology: https://510kreport.com/methodology