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510(k) Data Aggregation

    K Number
    K081042
    Device Name
    MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES
    Date Cleared
    2008-09-03

    (145 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    BSD MEDICAL SYSTEMS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MicroThermX®-100 Microwave Ablation System (MTX-100) delivers microwave energy for coagulation (ablation) of soft tissue. The system is not intended for use in cardiac procedures. The MTX-100 microwave applicators, which are inserted using the provided OTN catheters, may be used in open surgical as well as percutaneous ablation procedures. Optional temperature sensors may be used to monitor tissue temperatures.
    Device Description
    The MicroThermX®-100 Microwave Ablation System (MTX-100) delivers microwave energy for coagulation (ablation) of soft tissue. The delivery of microwave energy is controlled by time and power parameters set by the operator. The system consists of a mobile generator, generator cart, microwave applicators, Over-The-Needle (OTN) catheters for applicator can minorwing and optional temperature sensors and temperature sensor positioning tubes. The mobile generator is comprised of a computer, microwave generator, theoring the based temperature monitoring system, and thermal calibration well. The operator interface is via a touchscreen monitor.
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