# K103465: Synapse 3D Cardiac Tools

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Jan 31, 2011 after 68 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: 6 generations back to K954874 (1996). 25 ancestors in all.
20 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)
- K061326: Voxar 3D Enterprise with Cardiametrix, Barcoview Mis Edinburgh (2006) Summary page 2.
- K091262: MR Cardiac Function Analysis, Ziosoft, Inc. (2009) Summary page 2.
- K061370: Cardiq Fusion, GE Healthcare (2006) Summary page 2.

## Most influential descendants
- K120636: Synapse 3D Cardiac Tools (2012), 19 descendants of its own
- K171222: Vitrea Software Toshiba Package; VSTP-001A (2017), 12 descendants of its own
- K173088: Vitrea Software Toshiba Package VSTP-001A (2018), 11 descendants of its own
- K183013: Vitrea Software Package, VSTP-001A (2018), 9 descendants of its own
- K192923: Vitrea Software Package (2020), 8 descendants of its own

## Indications for use
Synapse 3D Cardiac Tools is medical imaging software used with Synapse 3D Basic Tools 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. Synapse 3D Cardiac Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including, CT, MR, NM, and XA. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. Addition to the tools with Synapse 3D Basic Tools, Synapse 3D Cardiac Tools provides the tools for specific clinical applications which provide targeted workflows, custom UI, targeted measurements and reporting functions including: >Functional cardiac analysis for CT left ventriculography images: which is intended to evaluate the functional characteristics of heart >Functional cardiac analysis for non contrasted MR heart images: which is intended to evaluate the functional characteristics of heart >Coronary artery analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries >Calcium scoring for non contrasted CT heart images: which is intended for non - invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms >Cardiac Fusion: which is intended to analyze cardiac anatomy and pathology with a fused image of functional data (e.g. NM image, Bulls eye) and anatomical data.

Source page: https://510kreport.com/device/K103465
Methodology: https://510kreport.com/methodology