# K210831: OnQ Neuro

- Pathway: 510(k) (Traditional)
- Applicant: Cortechs Labs, Inc.
- Decided: Nov 19, 2021 after 245 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 11 generations back to K913770 (1991). 103 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162955: Multi-Modality Tumor Tracking (MMTT) application, Philips Medical Systems Nederland B.V. (2016) Summary page 4.

## Most influential descendants
- K250416: GBrain MRI (2025), 1 descendant of its own
- K252362: GBrain MRI (2025), 0 descendants of its own
- K240680: CDM Insights (2024), 0 descendants of its own

## Indications for use
OnQ Neuro is a fully automated post-processing medical device software intended for analyzing and evaluating neurological MR image data. OnQ Neuro is intended to provide automatic segmentation, quantification, and reporting of derived image metrics. OnQ Neuro is additionally intended to provide automatic fusion of derived parametric maps with anatomical MRI data. OnQ Neuro is intended for use on brain tumors, which are known/confirmed to be pathologically diagnosed cancer. OnQ Neuro is intended for comparison of derived image metrics from multiple time-points. The physician retains the ultimate responsibility for making the final diagnosis and treatment decision.

Source page: https://510kreport.com/device/K210831
Methodology: https://510kreport.com/methodology