# K250416: GBrain MRI

- Pathway: 510(k) (Traditional)
- Applicant: Galileo Cds, Inc.
- Decided: Apr 11, 2025 after 57 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: 12 generations back to K913770 (1991). 107 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210831: OnQ Neuro, Cortechs Labs, Inc. (2021) Summary page 8.
- K232231: QP-Brain®, Quibim S.L. (2023) Summary page 8.

## Most influential descendants
- K252362: GBrain MRI (2025), 0 descendants of its own

## Indications for use
GBrain MRI is a post processing medical device software intended for analyzing and quantitatively reporting signal hyperintensities in the brain on FLAIR MR images in the context of diagnostic radiology. GBrain MRI is intended to provide automatic segmentation, quantification, and reporting of derived image metrics. It is not intended for detection or specific diagnosis of any disease nor for the detection of signal hyperintensities. GBrain MRI should not be used in-lieu of a full evaluation of the patient's MRI scans. The physician retains the ultimate responsibility for making the final patient management and treatment decisions.

Source page: https://510kreport.com/device/K250416
Methodology: https://510kreport.com/methodology