OptimMRI (v2)
Rebrain, SASOptimMRI (v2) is a software application that processes MRI brain images to generate detailed 3D annotated models highlighting specific brain regions. It helps clinicians in planning neurosurgical procedures by localizing critical brain nuclei, thus supporting accurate functional planning and improving surgical outcomes.
Intended Use
OptimMRI is a software application intended to aid qualified medical professionals in processing, visualizing, and interpreting anatomical structures from medical images. It processes pre-operative DICOM compatible MR images to generate 3D annotated models of the brain to aid neurosurgical functional planning and localize specific brain regions like STN and VIM.
Technology
OptimMRI (v2) reads DICOM compatible pre-operative MR images and uses advanced image processing techniques and machine learning models trained on a proprietary clinical database. It generates 3D annotated models of targeted brain regions and outputs data compatible with neurosurgical planning software supporting 3D DICOM format. The software runs as a web-based application.
Performance
Verification and validation testing confirmed the software functions as specified and performs similarly to the predicate device. Performance evaluation showed at least 90% of surface distances of the VIM region were within 2.0mm accuracy compared to reference devices. Minor software modifications did not raise any new safety or efficacy concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/15/2024
28 days - 2
FDA Approval
8/12/2024
Other devices from Rebrain, SAS
- OptimMRI2023 • 510K
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