# K101662: Synapse 3D Basic Tools

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Jul 26, 2010 after 42 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: 7 generations back to K913770 (1991). 31 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070831: Voxar 3D Enterprise with Colonmetrix and Pet/CT Perfusion, Barcoview Mis Edinburgh (2007) Summary page 2.
- K061214: Aquariusaps Server, Terarecon,Inc. (2006) Summary page 2.

## Most influential descendants
- K120361: Synapse 3D Base Tools (2012), 13 descendants of its own
- 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

## Indications for use
The Synapse 3D Basic Tools Software is medical imaging software that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting, and treatment planning. The Synapse 3D Basic 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. The Synapse 30 Basic Tools Software provides several levels of tools to the user: > Basic imaging tools for general images, such as 20 viewing, volume rendering and 30 volume viewing, orthogonal I oblique I curved Multi-Planar Reconstructions (MPR), Maximum (MIP), Average (RaySum) and Minimum (MinIP) Intensity Projection, 40 volume viewing, image fusion, image subtraction, CT PET fusion, surface rendering, sector and rectangular shape MPR image viewing, 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.

Source page: https://510kreport.com/device/K101662
Methodology: https://510kreport.com/methodology