Quantib ND
Quantib BVQuantib ND is an AI-powered software that processes MRI brain scans to automatically identify and measure volumes of various brain structures and white matter hyperintensities. It provides 3D visualizations and quantitative data to assist medical professionals in evaluating brain images and supporting quantitative reporting, making brain MR image assessment more precise and efficient.
Intended Use
Quantib ND is intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MR images, providing segmentations, visualizations, and volumetric measurements of brain structures and white matter hyperintensities to assist trained medical professionals in evaluation and quantitative reporting.
Technology
Quantib ND is a post-processing module for Myrian software that automatically segments brain structures using atlas-based segmentation of 3D T1-weighted and T2-weighted FLAIR MR images. It provides 3D visualization, volume quantification, and comparison to reference population centiles, with both baseline and longitudinal analysis capabilities.
Performance
Performance testing included validation of automatic segmentation volumes and segmentations against manual segmentations using multiple datasets, showing high Dice indices (up to 0.98) for brain structures and acceptable accuracy for white matter hyperintensities (average Dice 0.61). Testing was done on data from multiple vendors with various scan settings.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/18/2018
3 months - 2
FDA Approval
12/27/2018
Other devices from Quantib BV
- Quantib Prostate2023 • 510K
- Quantib Prostate2022 • 510K
- Quantib ND2022 • 510K
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