# K243762: Synapse 3D Base Tools (V7.0)

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: May 21, 2025 after 166 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: 11 generations back to K913770 (1991). 42 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221677: Synapse 3D Base Tools v6.6, Fujifilm Corporation (2022) Summary page 5.

## Most influential descendants
- K254189: Synapse 3D Base Tools (V7.2) (2026), 0 descendants of its own

## 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, 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 (MinlP) 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, dual energy image viewing. * Imaging tools for MR images including delayed enhancement image viewing, diffusion-weighted MRI image viewing. The intended patient population for all applications implemented as base tools is limited to adult population (over 22 years old).

Source page: https://510kreport.com/device/K243762
Methodology: https://510kreport.com/methodology