Turn this list into an evaluation

Each entry is an FDA submission, not a distinct commercial offer. Inspect the exact record before comparing evidence, asking for a quote or planning an integration.

Prepare with a buyer guide:

Clinical guide links appear when this list contains a current reviewed example. They do not classify or endorse the other entries. All buyer guides · Compare exact records · Documented families

FDA-cleared K242054

OptimMRI (v2)

Rebrain, SAS

Authorized purpose: OptimMRI is intended to aid qualified medical professionals in processing, visualizing, and interpreting anatomical structures from medical images. It can process preoperative DICOM-compatible MR images to generate three-dimensional annotated brain models and support localization of the subthalamic nuclei and ventral intermediate nucleus regions with other clinical methods.

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

OptimMRI

RebrAIn, SAS

Authorized purpose: OptimMRI processes preoperative DICOM-compatible MR images to generate three-dimensional annotated brain models that aid neurosurgical functional planning and may aid localization of the subthalamic nuclei and ventral intermediate nucleus regions when used with other clinical methods.

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