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510(k) Data Aggregation

    K Number
    K073059
    Device Name
    PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM
    Manufacturer
    HITACHI, LTD., POWER SYSTEMS GROUP
    Date Cleared
    2007-12-10

    (41 days)

    Product Code
    LHN
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    HITACHI, LTD., POWER SYSTEMS GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hitachi's PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
    Device Description
    The PROBEAT with DSSS is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. The PBTS is designed to be safe and reliable. The equipment to perform the above work is comprised of two main components. One is a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered. The other is the equipment necessary to generate the proton beam and direct it to the beam delivery system.
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    K Number
    K053280
    Device Name
    PROBEAT
    Manufacturer
    HITACHI, LTD., POWER SYSTEMS GROUP
    Date Cleared
    2006-03-09

    (106 days)

    Product Code
    LHN
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    HITACHI, LTD., POWER SYSTEMS GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hitachi's PROBEAT is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
    Device Description
    The PROBEAT is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose and dose distribution to the prescribed patient treatment site. The equipment is comprised of two main components. One is a beam delivery system whose primary responsibility is to ensure that the above listed prescription parameters are properly delivered. The other is the equipment necessary to generate the proton beam and direct it to the beam delivery system.
    Ask a Question

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