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