Galileo CDS, Inc radiology AI products

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Radiology AI pricing and total cost of ownership

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FDA-cleared K252362

GBrain MRI

Galileo CDS, Inc

Authorized purpose: 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

Detection and CADe Quantification and segmentation

FDA-cleared K250416

GBrain MRI

Galileo CDS, Inc

Authorized purpose: 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

Detection and CADe Quantification and segmentation