# K161322: CT CoPilot

- Pathway: 510(k) (Traditional)
- Applicant: Zepmed, LLC
- Decided: Dec 7, 2016 after 210 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: 1 generation back to K061855 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061855: Neuroquant, Cortechs Labs, Inc. (2006) Summary page 4.

## Indications for use
CT CoPilotTM is intended for automatic labeling, visualization and volumetric quantification of segmentable structures from sets of CT images of the brain. This software is intended to automate the current manual process of identifying, labeling and quantifying structures identified on CT images of the brain and to provide automated registration and reformatting of data.

Source page: https://510kreport.com/device/K161322
Methodology: https://510kreport.com/methodology