# K171328: cNeuro cMRI

- Pathway: 510(k) (Traditional)
- Applicant: Combinostics OY
- Decided: Jan 8, 2018 after 248 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 K061855 (2006). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 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 5.
- K161148: icobrain, Icometrix (2016) Summary page 5.

## Most influential descendants
- K231398: VUNO Med-DeepBrain (2023), 0 descendants of its own

## Indications for use
cNeuro cMRI is intended for automatic labeling, quantification and visualization of segmentable brain structures from a set of MR images. The software is intended to automate the current manual process of identifying, labeling and quantifying the segmentable brain structures identified on MR images. The intended user profile covers medical professionals who work with medical imaging. The intended operational environment is an office-like environment with a computer.

Source page: https://510kreport.com/device/K171328
Methodology: https://510kreport.com/methodology