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FDA-cleared K240680

CDM Insights

Oxford Brain Diagnostics Ltd

Authorized purpose: Assist trained healthcare practitioners in viewing, analyzing, quantifying, and evaluating MR brain images of adults older than 45 years, including segmentation, normative comparison, and reporting.

Modality
MRI
Anatomy
Brain, including individual brain structures, cortical regions, and white matter hyperintensities.
Decision
2024-12-06