# K141514: Synapse 3D Tensor Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Meidcal Systems U.S.A.,Inc.
- Decided: Sep 3, 2014 after 86 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). 54 ancestors in all.
No later device cites it as a predicate yet.
3 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113701: Visia Neuro, MeVis Medical Solutions AG (2012) Summary page 5.
- K120361: Synapse 3D Base Tools, Fujifilm Medical Systems U.S.A, Inc. (2012) Summary page 5.
- K113456: Ready View, Ge Healthcare (Ge Medical Systems Scs) (2012) Summary page 5.

## Indications for use
Synapse 3D Tensor Analysis is medical imaging software used with Synapse 3D Base Tools to accept, display, and process DICOM compliant 2D and 3D medical images acquired from MR for the purpose of viewing of local water diffusion properties and directional dependence of the diffusion in the white matter. It is intended to be used by trained medical professionals in reading, interpreting, reporting, screening and treatment planning. Addition to the general 2D and 3D image processing and measurement tools available in Synapse 3D Base Tools, Synapse 3D Tensor Analysis provides custom workflows, UI, and reporting functions for tensor analysis with neck and head MR images. It includes display of diffusion and FA color map images, white matter tractography, dynamic review in MR, vessel and body visualization with registration of MR, CT, XA, PET and NM.

Source page: https://510kreport.com/device/K141514
Methodology: https://510kreport.com/methodology