# K061855: Neuroquant

- Pathway: 510(k) (Traditional)
- Applicant: Cortechs Labs, Inc.
- Decided: Aug 10, 2006 after 41 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
No predicates in its family tree.
57 later devices descend from it; 6 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K170981: NeuroQuant (2017), 28 descendants of its own
- K161148: icobrain (2016), 22 descendants of its own
- K180326: icobrain (2018), 19 descendants of its own
- K181939: icobrain (2018), 18 descendants of its own
- K211222: qER-Quant (2021), 13 descendants of its own

## Indications for use
NeuroQuantTM is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmental brain structures identified on MR images.

Source page: https://510kreport.com/device/K061855
Methodology: https://510kreport.com/methodology