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510(k) Data Aggregation

    K Number
    K060187
    Device Name
    TOPSLANE DMLC
    Manufacturer
    TOPSLANE INTERNATIONAL, LLC
    Date Cleared
    2006-07-27

    (184 days)

    Product Code
    IXI, IYE
    Regulation Number
    892.5710
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOPSLANE INTERNATIONAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TOPSLANE DMLC is a dynamic multileaf collimator designed to be mounted on the linear accelerator. It is intended to shape the specific fields, either in static or dynamic mode, to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
    Device Description
    TOPSLANE DMLC is a dynamic multileaf collimator designed to be mounted on the various linear accelerator. It comprises multiple motorized tungsten leafs and By controlling each leaf to the designed position according to the software. treatment planning system (TPS), TOPSLANE DMLC is intended to shape the specific field, either in static or dynamic mode. TOPSLANE DMLC can perform different field shaping methods, such as Static Field Shaping, or Step and Shoot IMRT Field Shaping or Sliding Window IMRT Field Shaping.
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