# K142521: Synapse 3D Liver and Kidney Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Meidcal Systems U.S.A.,Inc.
- Decided: Dec 1, 2014 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: 12 generations back to K913770 (1991). 103 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121213: Vitreaadvanced, Vital Images, Inc. (2012) Summary page 6.
- K131498: Iqqa-Liver Multimodality Software, Edda Technology, Inc. (2013) Summary page 6.

## Most influential descendants
- K151988: Visible Patient Suite (2015), 4 descendants of its own
- K212896: Visible Patient Suite (2021), 3 descendants of its own
- K250237: InferOperate Suite (2025), 1 descendant of its own
- K260973: InferOperate Suite (2026), 0 descendants of its own
- K233457: RUS (2024), 0 descendants of its own

## Indications for use
Synapse 3D Liver and Kidney Analysis is medical imaging software used with Synapse 3D Base 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 Liver and Kidney Analysis accepts DICOM compliant medical images. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. Addition to Synapse 3D Base Tools, Synapse 3D Liver and Kidney Analysis uses contrast enhanced images of the body and provides custom workflows and UI, and reporting functions for liver and kidney analysis including, liver and peripheral organ segmentation, and tumor segmentation. Also segmentation of intrahepatic and peripheral vessels as well as the approximation of vascular territories is provided using contrast enhanced computed tomographic images.

Source page: https://510kreport.com/device/K142521
Methodology: https://510kreport.com/methodology