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FDA-cleared K231398

VUNO Med-DeepBrain

VUNO Inc.

Authorized purpose: Automate labeling, visualization, and volumetric quantification of segmentable brain structures from MR images for trained medical-imaging professionals.

Modality
MRI
Anatomy
Brain, including segmentable cortical/subcortical structures, vessels, and WMH/lesion regions.
Decision
2023-10-04