Intended Use

Automatic labeling, spatial measurement, and volumetric quantification of brain structures from a set of low-field MR images, returning annotated and segmented images, color overlays, and reports.

Technology

BrainInsight is a fully automated MR imaging post-processing software that uses a proprietary internal pipeline incorporating machine learning for brain segmentation, ventricle segmentation, and midline shift measurements. It operates on standard computing platforms or cloud servers and supports DICOM input and output formats, providing volumetric measurements, segmented color overlays, and morphometric reports.

Performance

Performance testing included software evaluations to confirm cybersecurity, data protection, segmentation accuracy, midline shift measurements, 3D coordinate alignment, ventricle segmentation, skull stripping, data quality control, audit trails, and software controls. No clinical data were required for equivalence.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    8/24/2020

    4 months
  • 2

    FDA Approval

    1/7/2021

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