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510(k) Data Aggregation

    K Number
    K063456
    Device Name
    SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM
    Manufacturer
    TOPEX, INC
    Date Cleared
    2007-01-09

    (55 days)

    Product Code
    JAD
    Regulation Number
    892.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOPEX, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SRT-100 is a low energy x-ray system intended for superficial radiotherapy treatment of primary malignant epithelial neoplasms of the skin. Typical applications include basal cell carcinoma, squamous cell carcinoma, metatypic carcinoma, cutaneous appendage carcinoma and Kaposi's sarcoma.
    Device Description
    The Topex, Inc. SRT100 is a complete, stand-alone, x-ray radiation therapy system. It consists of two major separate components: Control Console and Base Unit. The Control Console is a specifically designed module housing the switches and indicators used by the operator to set up and execute x-ray exposures. The Base Unit is a cabinet containing the high voltage generator, power supply components, cooling system, and an arm/positioning mechanism on which the x-ray tube housing assembly is mounted. A series of Applicators is included, which are affixed to the x-ray port on the x-ray tube housing assembly to limit the x-ray beam and provide fixed Source-to-Skin Distance (SSD). The X-ray Tube Housing Assembly contains a motorized filter mechanism which move the appropriate beam filter into the beam path depending on the kV setting selected by the operator.
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