# K120361: Synapse 3D Base Tools

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Apr 6, 2012 after 60 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 8 generations back to K913770 (1991). 39 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110573: Ready View, Ge Healthcare (Ge Medical Systems Scs) (2011) Summary page 2.
- K923077: Advantage Windows 3D Option and Dentascan Option, GE Medical Systems (1993) Summary page 2.
- K101662: Synapse 3D Basic Tools, Fujifilm Medical System U.S.A., Inc. (2010) Summary page 2.

## Most influential descendants
- K203103: Synapse 3D, Synapse 3D Base Tools v6.1 (2021), 5 descendants of its own
- K221677: Synapse 3D Base Tools v6.6 (2022), 4 descendants of its own
- K151988: Visible Patient Suite (2015), 4 descendants of its own
- K212896: Visible Patient Suite (2021), 3 descendants of its own
- K250237: InferOperate Suite (2025), 1 descendant 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 (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, 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.

Source page: https://510kreport.com/device/K120361
Methodology: https://510kreport.com/methodology