Quantib Brain 1.2
Quantib BVQuantib Brain 1.2 is a software tool that assists radiologists by automatically identifying and measuring different brain structures and white matter abnormalities from MRI scans. It provides visualizations and quantitative data to support evaluation and reporting, enabling better assessment of brain health over time by comparing multiple scans of the same patient.
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 magnetic resonance images with associated volumetric measurements and white matter hyperintensity quantification to assist trained medical professionals in evaluation and quantitative reporting.
Technology
The software operates as a post-processing analysis plugin for GE Advantage Workstation and Server platforms. It uses multiple atlases consisting of 3D T1-weighted MRI and label maps to segment brain tissues (grey matter, white matter, cerebrospinal fluid) and white matter hyperintensity candidates. White matter hyperintensity segmentations require user review and editing before validation. The software supports longitudinal analysis comparing multiple MRI exams of the same patient, providing volumetric differences and changes over time.
Performance
Performance testing included various software verification and validation steps (unit tests, functional tests, integration tests, algorithm tests, code reviews), algorithm performance assessment of a new longitudinal white matter hyperintensity labeling algorithm, and risk analyses. The longitudinal WMH labeling algorithm was validated on 12 datasets, showing 99.6% volume agreement with manual labeling. Changes do not affect core segmentation algorithm performance. Overall, the device was found as safe and effective as its predicate.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/28/2016
2 months - 2
FDA Approval
1/6/2017
Other devices from Quantib BV
- Quantib Prostate2023 • 510K
- Quantib Prostate2022 • 510K
- Quantib ND2022 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.