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    K Number
    K232489
    Device Name
    VenusX
    Manufacturer
    LinaTech LLC
    Date Cleared
    2024-04-12

    (239 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    LinaTech LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VenusX radiotherapy delivery system is intended to provide precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
    Device Description
    The VenusX Radiotherapy System is a medical linear accelerator that delivers therapeutic radiation to patient in accordance with the physician's prescription. It supports CRT /IMRT Treatment Techniques (Mode). The system consists of a photon therapeutic 6 MV X-ray radiation beam producing component with a photon diagnostic kV X-ray radiation beam producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room.
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