Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K242054
    Device Name
    OptimMRI (v2)
    Manufacturer
    Date Cleared
    2024-08-12

    (28 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rebrain, SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    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.
    Device Description
    OptimMRI (v2) 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 brain to allow qualified medical professionals to display, review, analyze, annotate, interpret, export, and plan neurosurgical functional procedures. OptimMRI (v2) is used as an aid to localize regions of the brain such as Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM) using advanced image processing techniques and machine learning models trained on a proprietary clinical database. The software supports workflow for creating pre-operative plans prior to carrying out the intraoperative procedure. OptimMRI (v2) is configured as web-based software and its output is compatible with neurosurgical planning software supporting 3D DICOM format. Three models have been implemented within OptimMRI (v2) to segment the following regions of interest of the brain: -STN region of interest (STN itself) -Inferior part of the Ventral Intermediate Nucleus (VIM) and Zona Incerta -Inferior-lateral part of the Ventral Intermediate Nucleus (VIM)
    Ask a Question

    Ask a specific question about this device

    K Number
    K230150
    Device Name
    OptimMRI
    Manufacturer
    Date Cleared
    2023-07-21

    (183 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    RebrAIn, SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    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.
    Device Description
    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).
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1