OptimMRI (v2)
Rebrain, Sas
REBRAIN
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3030088963 | 3030088963 | REBRAIN | 1 | N | 2026-01-01 | PTIB, Hopital Xavier Arnozan, Avenue du Haut Leveque PESSAC Gironde FR 33600 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 323123 | 2037708602 | K242054 | OptimMRI (v2) | QIH | 2024-08-12 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QIH | 1 | 2024-08-12 |
PMN#
OptimMRI
Rebrain, Sas
GUDID#
OptimMRI (v2) - OptimMRI is a software application intended to aid qualified medical professionals in processing, visualizing, and interpreting anatomical structures from medical images. The software can be used to process pre-operative DICOM compatible MR images to generate 3D annotated models of the brain that aid the user in neurosurgical functional planning. The annotated MR images can further be used in conjunction with other clinical methods as an aid in localization of the Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM) regions of interest.
2024-10-22
OptimMRI - OptimMRI is a software application for processing medical images of the brain that enables 3D visualization and analysis of anatomical structures. Specifically, the software can be used to read DICOM compatible pre-operative MR images acquired by commercially available imaging devices. These images can be processed to generate 3D markers in specific regions of the anatomy to allow qualified medical professionals to display, review, analyze, annotate, interpret, export, and plan neurosurgical functional procedures. OptimMRI is used as an aid to localize regions of the brain such as Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM).
2023-12-08