# K181773: Synapse 3D Optional Tools

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: Sep 25, 2018 after 84 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: 9 generations back to K913770 (1991). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120361: Synapse 3D Base Tools, Fujifilm Medical Systems U.S.A, Inc. (2012) Summary page 4.

## Indications for use
Synapse 3D Optional Tools is medical imaging software used with Synapse 3D Base Tools that is intended to provide trained medical professionals, with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Optional Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including CT, MR. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. Addition to the tools in Synapse 3D Base Tools, Synapse 3D Optional Tools provides: * Imaging tools for CT images including virtual endoscopic viewing. * Imaging tools for MR images including delayed enhancement image viewing and diffusion-weighted MRI data analysis.

Source page: https://510kreport.com/device/K181773
Methodology: https://510kreport.com/methodology