Icobrain is a software that automatically identifies and measures volumes of brain structures in MRI scans. It helps clinicians by automating the manual process of labeling and quantifying brain regions, supports analysis at single or multiple time points, and generates detailed reports with volumetric measures to assist in diagnosis and tracking of neurological conditions.
Intended Use
Icobrain is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images to automate the manual process of identifying, labeling and quantifying volumes in MR images.
Technology
Icobrain consists of two image processing pipelines (icobrain cross and icobrain long) which use T1-weighted and FLAIR MRI images, converting DICOM images to NIFTI, performing segmentation based on a probabilistic atlas and image intensities, then calculating volumes and volume changes, and producing reports with visualization overlays.
Performance
Performance testing included accuracy and reproducibility validation on 349 subject datasets with healthy controls and various neurological patient groups. Experiments compared volumes and volume changes to manual ground truth and test-retest data, achieving average Pearson correlation of 0.90 and intraclass correlation of 0.89, meeting acceptance criteria.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/22/2016
3 months - 2
FDA Approval
8/9/2016
Other devices from Icometrix
- icobrain aria2024 • 510K
- icobrain-ctp2020 • 510K
- Icobrain2019 • 510K
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