# K130542: Synapse 3D Lung and Abdomen Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Jun 14, 2013 after 105 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: 8 generations back to K954355 (1995). 12 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120648: Synapse 3D Lung and Abdomen Analysis, Fujifilm Medical System U.S.A., Inc. (2012) Summary page 2.
- K083227: Vida Pulmonary Workstation 2 (PW2), Vida Diagnostics, Inc. (2008) Summary page 2.

## 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
- K223556: DeepCatch (2023), 1 descendant of its own
- K181892: Ziostation2 (2018), 1 descendant of its own

## Indications for use
Synapse 3D Lung and Abdomen Analysis 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 Lung and Abdomen Analysis accepts DICOM compliant medical images acquired from CT. 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 Lung and Abdomen Analysis is intended to; - use non-contrast and contrast enhanced computed tomographic images of the lung, provide custom workflows and Ul, and reporting functions for lung analysis including boundary detection and volume calculation for pulmonary nodules in the lung based on the location specified by the user, segmentation of bronchial tubes in the lung. approximation of air supply region by the user specified bronchial tube, identifying, displaying and processing low absorption regions in the lung. - use non-contrasted CT images and calculate subcutaneous fat and visceral fat areas in 2D and both volumes in 3D. - analyze a bronchus path to reach a lung nodule using the volume data collected with CT, and simulate insertion of bronchoscope into the path.

Source page: https://510kreport.com/device/K130542
Methodology: https://510kreport.com/methodology