FDA-cleared K242054

OptimMRI (v2)

Rebrain, SAS

OptimMRI is intended to aid qualified medical professionals in processing, visualizing, and interpreting anatomical structures from medical images. It can process preoperative...

Modality
MRI
Anatomy
Brain and subthalamic and ventral intermediate nucleus regions
Decision
2024-08-12
FDA-cleared K230150

OptimMRI

RebrAIn, SAS

OptimMRI processes preoperative DICOM-compatible MR images to generate three-dimensional annotated brain models that aid neurosurgical functional planning and may aid localization...

Modality
MRI
Anatomy
Brain, including the subthalamic nuclei and ventral intermediate nucleus regions of interest
Decision
2023-07-21