# K160150: Vitrea CT Colon Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Vital Images, Inc.
- Decided: Mar 16, 2016 after 55 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 K913770 (1991). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052632: VITREA2 Version 3.8 Medical Image Processing Software, Vital Images, Inc. (2005) Summary page 4.

## Indications for use
The separately-licensed CT Colonography option is intended for closely examining the lumen of the colon using features such as auto-segmentation, axial imaging, multi-planar reformatting, fly-through, simultaneous display of prone and supine images, and transparent wall view.

Source page: https://510kreport.com/device/K160150
Methodology: https://510kreport.com/methodology