FDA-cleared K252362

GBrain MRI

Galileo CDS, Inc

Post-processing segmentation, quantification, and reporting of brain signal hyperintensities on T2w FLAIR and T1w post-contrast MRI; not detection or specific disease diagnosis.

Modality
MRI
Anatomy
Brain signal hyperintensities
Decision
2025-08-22
FDA-cleared K250416

GBrain MRI

Galileo CDS, Inc

Post-processing automatic segmentation, quantification, and reporting of brain FLAIR hyperintensity volumes to support structural MRI review; not disease detection or diagnosis.

Modality
MRI
Anatomy
Adult brain, specifically T2-weighted FLAIR hyperintensities
Decision
2025-04-11