OnQ Neuro
CorTechs Labs, IncOnQ Neuro is an automated software device designed to analyze neurological MRI images, specifically for brain tumors. It performs automatic segmentation and quantification of tumor volumes and diffusion-weighted imaging data, helping clinicians assess tumor progression and treatment response more efficiently by providing quantitative and graphical image data that can be integrated into clinical workflows.
Intended Use
OnQ Neuro is a fully automated post-processing medical device software intended for analyzing and evaluating neurological MR image data, providing automatic segmentation, quantification, reporting of derived image metrics, and fusion with anatomical images for brain tumors confirmed to be cancer.
Technology
The software accepts DICOM images, automatically segments brain tumors, analyzes diffusion-weighted imaging data, produces quantitative volumetric data and parametric maps, and outputs DICOM files for integration into clinical systems. It runs standalone on cloud or hospital IT infrastructure and requires no user interface after installation.
Performance
Performance testing showed the software's automated segmentation accuracy is consistent with expert manual segmentation, using Dice similarity and correlation coefficients. Validation also tested diffusion modeling, report generation, and clinical acceptability, demonstrating the device is safe and effective for clinical use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/19/2021
8 months - 2
FDA Approval
11/19/2021
Other devices from CorTechs Labs, Inc
- NeuroQuant2024 • 510K
- NeuroQuant2017 • 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.