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FDA-cleared K241098

NeuroQuant

CorTechs Labs, Inc.

Authorized purpose: NeuroQuant automatically labels, visualizes, and volumetrically quantifies segmentable brain structures and lesions from MR images, optionally using T2 FLAIR and T2* GRE/SWI for lesion analysis; outputs require radiologist/neuroradiologist review and may be compared with reference percentiles.

Modality
MRI
Anatomy
Brain
Decision
2024-08-22
FDA-cleared K210831

OnQ Neuro

CorTechs Labs, Inc

Authorized purpose: Analyzes neurological MR images for automated segmentation, volumetric quantification, reporting, fusion, and longitudinal comparison of known pathologically confirmed brain tumors.

Modality
MRI
Anatomy
Brain; pathologically confirmed brain tumors
Decision
2021-11-19
FDA-cleared K170981

NeuroQuant

CorTechs Labs, Inc

Authorized purpose: NeuroQuant is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures and lesions from a set of MR images.

Modality
MRI
Anatomy
Brain
Decision
2017-09-07