Intended Use

NeuroQuant is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. It automates the manual process of identifying, labeling and quantifying brain volumes.

Technology

NeuroQuant is a fully automated MR post-processing software that uses an internal pipeline for artifact correction, atlas-based segmentation using a dynamic probabilistic neuroanatomical atlas, volume calculation, lesion quantification, and report generation. It includes automated quality control functions such as tissue contrast and atlas alignment checks, and supports DICOM file transfers for integration with clinical workflows.

Performance

Performance was validated by comparing NeuroQuant segmentations to expert manual segmentations and testing reproducibility on repeated scans. Dice coefficients for major brain structures ranged from 75% to 90%, lesion segmentation exceeded 80%, and volume differences were within clinically acceptable ranges, demonstrating accurate and reproducible results.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    4/3/2017

    5 months
  • 2

    FDA Approval

    9/7/2017

Other devices from CorTechs Labs, Inc

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