# K123566: Synapse 3D Colon Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Jan 22, 2013 after 63 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: 2 generations back to K954355 (1995). 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)
- K040126: Viatronix V3D Colon, Revision 1.3, Viatronix, Inc. (2004) Summary page 2.

## Indications for use
Synapse 3D Colon Analysis is medical imaging software used with Synapse 3D Base Tools to accept display, and process DICOM compliant 2D and 3D medical images acquired from CT for the purpose of viewing of a colon to detect polyps, masses, cancers, and other lesions. It is intended to be used by trained medical professionals in reading, interpreting, reporting, and screening. Addition to the general 2D and 3D image processing and measurement tools available in Synapse 3D Base Tools, Synapse 3D Colon Analysis provides custom workflows, UI, and reporting functions for colon analysis, including colon segmentation, detection of the centerline of colon, fly-through of the entire colon, various rendering and visualization of colon, comparing both prone and supine views, and electronic cleansing.

Source page: https://510kreport.com/device/K123566
Methodology: https://510kreport.com/methodology