# K120679: Synapse 3D Nodule Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Jun 1, 2012 after 87 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 K913770 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042694: Advanced Lung Analysis II, GE Medical Systems (2004) Summary page 2.

## Indications for use
Synapse 3D Nodule 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 Nodule Analysis accepts DICOM compliant medical images acquired from CT and PT. 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 Nodule Analysis is intended to; " use non-contrast and contrast enhanced computed tomography (CT) images, provie custom workflows and UI, and reporting functions for nodule analysis including boundary detection of nodules based on the location specified by the user, measurement of nodules, temporal comparison of nodule images, and fusion of a CT nodule image on a PT nodule image. > use positron emission tomography (PT) images, provide wustom workflows and UI, and reporting functions for nodule analysis including SLWV measurement of nodules with sphere VOl based on the location specified by the user, temporal comparison of nodule images, and fuision of a PT nodule image on a CT nodule image.

Source page: https://510kreport.com/device/K120679
Methodology: https://510kreport.com/methodology