Quantib Brain
Quantib BVQuantib Brain is a software application that automatically labels, visualizes, and measures brain structures and white matter lesions on MRI scans. It helps trained medical professionals by providing quantitative information to assist in the evaluation and assessment of brain MR images, supporting more informed and quantitative reporting in clinical settings.
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. It outputs segmentations and volumetric measurements for grey matter, white matter, cerebrospinal fluid, and visualizes and quantifies white matter hyperintensity candidates to aid medical professionals in evaluation and quantitative reporting.
Technology
Quantib Brain is post-processing software for GE Advantage Workstation and AWS Server platforms that uses volumetric viewer applications to automatically label, visualize, and quantify brain structures on 3D T1-weighted MR images, with additional T2-weighted FLAIR images used for white matter hyperintensity segmentation. It relies on multiple atlases with label maps for tissue segmentation and provides both absolute and relative volume measurements, requiring user review and validation of white matter hyperintensity segmentations before reporting.
Performance
Quantib Brain's accuracy in segmenting brain tissues and white matter hyperintensities was validated against manual segmentations on diverse datasets from multiple vendors. Dice indices for brain tissues ranged from 0.78 to 0.97, and for white matter hyperintensities the average Dice overlap was 0.61. Absolute differences in relative volumes were small, demonstrating comparable performance between the automatic segmentation and manual reference standards. The device was developed under ISO and IEC standards with comprehensive software testing and risk management.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/26/2017
2 months - 2
FDA Approval
3/9/2018
Other devices from Quantib BV
- Quantib Prostate2023 • 510K
- Quantib Prostate2022 • 510K
- Quantib ND2022 • 510K
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