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510(k) Data Aggregation

    K Number
    K172858
    Device Name
    PreOp
    Manufacturer
    Epilog
    Date Cleared
    2018-01-08

    (110 days)

    Product Code
    OLX
    Regulation Number
    882.1400
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    Epilog

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PreOp is intended for use by a trained/qualified EEG technologist or physician on both adult and pediativ subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.
    Device Description
    PreOp is medical device software that combines EEG data and MR images to visualize recorded EEG activity in 3D in the brain. PreOp can be subdivided in 3 main modules: 3D Electrical Source Imaging (i.e. 3D ESI), Report generation and Viewer generation. The device's input is the MRI and EEG data that are uploaded by the user to the PreOp cloud environment. The output of the device is a report containing the results of the visualization and the ability to evaluate the results in 3D using the 3D viewer. The user can access the output through the PreOp cloud environment.
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