# K200973: Synapse 3D Cardiac Tools

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporaton
- Decided: Aug 27, 2020 after 136 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: 13 generations back to K913770 (1991). 67 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130383: Synapse 3D Cardiac Tools, Fujifilm Medical System U.S.A., Inc. (2013) Summary page 4.

## Most influential descendants
- K220039: AutoSeg (2022), 1 descendant of its own
- K220727: inHEART MODELS (2022), 1 descendant of its own
- K243158: TeraRecon Aorta.CT (1.1.0) (2025), 0 descendants of its own
- K231683: inHEART Models (2024), 0 descendants of its own

## Indications for use
Synapse 3D Cardiac 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 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 in Synapse 3D Base 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 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. -Coronary artery analysis for MR heart images: which is intended for the qualitative and quantitative analysis of coronary arteries. -Calcium scoring for non-contrast 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. -Valve Analysis: which is intended for automatic extraction of the heart and aorta regions, automatic detection of the contour of the aorta and valves, measurement of the vicinity of the valves, measurement of the calcification area in the aorta and the valves. Placement of a virtual prosthetic valve. -MR parametric maps: which is provided for pixel maps for myocardial MR relaxation times.

Source page: https://510kreport.com/device/K200973
Methodology: https://510kreport.com/methodology