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FDA-cleared K252670

Alzevita

TOPIA MEDTECH LIMITED

Authorized purpose: Automated hippocampal labeling, visualization, and volumetric measurement from high-resolution T1-weighted brain MRI, with comparison to a normative healthy-control dataset acquired using standardized 1.5T/3T protocols.

Modality
MRI
Anatomy
Brain; hippocampus
Decision
2025-12-19