# K103720: Synapse 3D Lung and Abdomen Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Mar 16, 2011 after 85 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: 5 generations back to K930090 (1993). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023785: Lung Nodule Assessment and Comparison Option, Philips Medical Systems (Cleveland), Inc. (2003) Summary page 2.
- K011142: Aquarius Workstation, Terarecon,Inc. (2001)

## Indications for use
Synapse 3D Lung and Abdomen Analysis 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 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 Basic Tools, Synapse 3D Lung and Abdomen Analysis is intended to; * use non-contrasted and contrast enhanced computed tomographic images of the lung, perform boundary detection and volume calculation for pulmonary nodes in the lung based on the location specified by the user and display low absorption areas. * use non-contrasted CT images and calculate subcutaneous fat and visceral fat areas in 2D and both volumes in 3D.

Source page: https://510kreport.com/device/K103720
Methodology: https://510kreport.com/methodology