Quantib Brain 1
QUANTIB BVQuantib Brain 1 is an AI-powered software tool that automatically labels and measures the volumes of brain structures from MRI scans. It helps radiologists by providing quantitative data and visualization of brain tissue and white matter abnormalities to support diagnosis and reporting.
Intended Use
Quantib Brain is a non-invasive medical imaging processing application intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MR images to aid trained medical professionals in quantitative reporting.
Technology
Quantib Brain uses atlas-based segmentation with 3D T1-weighted MR images and additional T2-weighted FLAIR images for white matter hyperintensity segmentation, using histogram analysis and trained classifiers to improve accuracy. It plugs into GE Advantage Workstation or Server platforms as post-processing software.
Performance
Performance testing included comparison of Quantib Brain segmentations to manual segmentations on multiple vendor MR images. Dice overlap for brain tissues ranged 0.78-0.97, and for WMHs 0.61, with small absolute volume differences, supporting safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/20/2015
7 months - 2
FDA Approval
6/17/2016
Other devices from QUANTIB BV
- Quantib Prostate2023 • 510K
- Quantib Prostate2022 • 510K
- Quantib ND2022 • 510K
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