Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K213128
    Device Name
    IntraOp VSP Software Device
    Manufacturer
    Date Cleared
    2022-10-21

    (389 days)

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

    Xironetic, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    IntraOp VSP is a software device that is indicated for use with an augmented display which allows for visualization and orientation of 3D digital models of selected structures of a patient's anatomy. IntraOpVSP is intended to supplement conventional Virtual Surgical Planning (VSP) by facilitating perception of the shape and scale of a patient's anatomical targets for use in preoperative planning and heads-up 3D visualization during surgery. IntraOpVSP is not intended to provide diagnosis or to guide surgical instrumentation. It is not to be used for stereotactic procedures or surgical navigation. IntraOpVSP is intended for use by surgeons who have been trained to operate IntraOpVSP software is designed for use with performance-tested hardware specified in the User Manual.
    Device Description
    IntraOpVSP software displays 3D objects as holograms to inform the user on operative planning. It includes functions for 3D object spatial manipulation and orientation. IntraOpVSP software provides additional information to the surgeon by displaying holograms of the surgical plan, anatomical structures, and guides.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1