Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K141785
    Device Name
    MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIES
    Manufacturer
    Date Cleared
    2015-03-31

    (272 days)

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

    BSD MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MicroThermX Microwave Ablation System (MTX) delivers microwave energy for coagulation (ablation) of soft tissue. The system is not intended for use in cardiac procedures. The SynchroWave antennas may be used in open surgical procedures and in laparoscopic and percutaneous ablation procedures, using image guidance, including partial or complete ablation of non-resectable liver tumors. An optional Temperature sensor may be used to monitor tissue temperatures.
    Device Description
    The MicroThermX® Microwave Ablation System (MTX) delivers 915 MHz microwave energy for coagulation (ablation) of soft tissue. The procedure time and power parameters are operator selected via a touchscreen monitor. The system consists of a generator and pump attached to a mobile cart or tabletop stand, sterile disposable SynchroWave antennas with cooling circuit, and optional disposable TempSure temperature sensors. The closed cooling circuit consists of a bag of sterile isotonic saline (not supplied by Perseon), disposable, single-use cooling circuit tubing and connectors; and fluid pathway channels within each single-use antenna. A reusable pump circulates isotonic saline through the cooling circuit.
    Ask a Question

    Ask a specific question about this device

    K Number
    K100786
    Device Name
    MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX
    Manufacturer
    Date Cleared
    2010-08-13

    (147 days)

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

    BSD MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MicroThermX Microwave Ablation System (MTX) delivers microwave energy for coagulation (ablation) of soft tissue. The system is not intended for use in cardiac procedures. The SynchroWave antennas may be used in open surgical as well as percutaneous ablation procedures. An optional temperature sensor may be used to monitor tissue temperatures.
    Device Description
    The MicroThermX Microwave Ablation System (MTX-180 or MTX) delivers 915 MHz 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 operator can select up to 3 applicators to ablate target tissue. The MTX-180 consists of a mobile cart with generator and closed-circuit antenna cooling system, microwave antennas, and an optional temperature sensor. The mobile generator is comprised of a computer, microwave generator, and thermistor-based temperature monitoring system. The operator interface is via the touchscreen monitor of the mobile generator. The cooling system consists of a bag of sterile isotonic saline (not supplied by BSD); peristaltic pump; cooling circuit tubing and connectors; and fluid pathway channels within the antenna. The MTX-180 is designed to: Deliver controlled microwave energy to induce coagulation of soft tissue; Provide repeatable ablation zone geometries for a given set of ablation parameters (repeatability demonstrated in ex-vivo studies performed in nonperfused animal tissue); Be used in an intraoperative or minimally invasive percutaneous procedure; Utilize a single SynchroWave antenna or synchronous operation of 2 or 3 antennas during a single procedure to induce larger zones of ablation .; and Utilize an optional sensor to monitor the temperature of non-target tissue during a procedure.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1