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FDA-cleared K192531

QyScore Software

Qynapse

Authorized purpose: Automatic labeling, visualization, and volumetric quantification of segmentable brain structures and lesions from MR images, with comparison to reference percentile data; not intended for clinical scenarios requiring evaluation of the number of white matter hyperintensities.

Modality
MRI
Anatomy
Brain structures and lesions, including grey matter, white matter, hippocampus, amygdala, and white matter hyperintensities
Decision
2019-12-13