Quantib ND
Quantib B.V.Quantib ND is a software application that automatically labels, visualizes, and measures volumes of brain structures and white matter abnormalities from MR brain scans. It helps radiologists by providing detailed quantitative data and visual segmentations to assist in assessing and tracking neurological conditions.
Intended Use
Quantib ND is a non-invasive medical imaging processing application that is intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures from a set of magnetic resonance (MR) images. The Quantib ND output consists of segmentations, visualizations and volumetric measurements of brain structures and white matter hyperintensities. Volumetric measurements may be compared to reference centile data. It is intended to provide the trained medical professional with complementary information for the evaluation and assessment of MR brain images and to aid the trained medical professional in quantitative reporting.
Technology
Quantib ND functions as an extension to the Quantib AI Node software platform providing workflows for brain structure and white matter hyperintensity segmentation and volumetric quantification from 3D T1-weighted and T2-weighted FLAIR MR images. The system uses atlas-based segmentation with label maps and outputs volumetric data along with segmentations. User interaction includes reviewing and editing white matter hyperintensity segmentation before validation. It is a server-client model allowing report generation and direct export to PACS.
Performance
Quantib ND was evaluated by comparing automatic segmentations and volumetric measurements against manual segmentation in multiple datasets covering brain tissue, cerebrospinal fluid, intracranial volume, hippocampus, brain lobes, and cerebellum. Dice indices ranged from 0.78 to 0.99 indicating good overlap. White matter hyperintensity segmentation was also validated showing an average Dice overlap of 0.61. Volume differences were low, demonstrating accuracy. Quality assurance included risk analysis, code reviews, unit and system testing, and usability engineering.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/29/2021
1 month - 2
FDA Approval
1/14/2022
Other devices from Quantib B.V.
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