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510(k) Data Aggregation

    K Number
    K182768
    Device Name
    TMS-Cobot TS MV
    Manufacturer
    Date Cleared
    2019-02-17

    (142 days)

    Product Code
    Regulation Number
    882.5805
    Why did this record match?
    Product Code :

    QFF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Axilum Robotics TMS-Cobot TS MV is a computer controlled electromechanical arm indicated for spatial positioning and orientation of the treatment coil of the MagVita TMS Therapy System.
    Device Description
    Axilum Robotics TMS-Cobot TS MV is a computer controlled electromechanical arm based on collaborative robotics technology, providing guidance for the positioning and orientation of a Transcranial Magnetic Stimulation (TMS) coil - connected to its stimulator - under the supervision of an optical tracking system. Axilum Robotics TMS-Cobot TS MV comprises the electromechanical collaborative arm on its cart, its optical tracking system, with its software, 3D camera and a coil adaption kits with its mechanical adaptor, to fix the coil on the robotic arm, as well as a contact sensor. The device is intended to be used in combination with the TMS stimulator, treatment coil and treatment chair from the previously-cleared MagVenture MagVita system.
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