# K140920: Syngo.CT Colonography

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Dec 3, 2014 after 237 days
- Product code: NWE (Colon Computed Tomography System, Computer Aided Detection)
- 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: 4 generations back to K954355 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042605: Colongraphy Software Package with Extended Functionality, Siemens AG Medical Solutions (2004) Summary page 5.

## Indications for use
syngo.CT Colonography is used for easy-to-perform and efficient inspection of the colonic surface. It facilitates the search and diagnosis of colon lesions. The workflow management ensures that the required data and tools are offered to you according to your role and task. syngo.CT Colonography is a clinical post-processing workflow for basic virtual colonoscopy. It is designed to support the following image reconstruction techniques: • Multiplanar Reconstruction (MPR) • Volume Rendering Technique (VRT) • Perspective surface shaded display (pSSD) The following evaluation tools are provided with this workflow: • Virtual Flight • Panoramic View • Polyp Lens • Stool Tagging • Stool Subtraction • Polyp Enhanced Viewing (PEV) • Movie syngo.CT Colonography supports reporting with appropriate reporting tools such as lesion location, lesion characterization, and key image creation. Combining enhanced commercially available digital image processing tools with an optimized workflow and reporting tools, the software is designed to support the physician on confirming the presence or absence of physician identified colon lesions (for example, polyps) in addition to evaluation, documentation, and follow-up of any such lesions using standard or low-dose spiral CT scanning.

Source page: https://510kreport.com/device/K140920
Methodology: https://510kreport.com/methodology