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510(k) Data Aggregation

    K Number
    K232032
    Device Name
    PROBEAT-FR
    Manufacturer
    Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
    Date Cleared
    2024-01-12

    (189 days)

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

    Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PROBEAT-FR 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-FR 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.
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    K Number
    K220883
    Device Name
    Small Field Applicator
    Manufacturer
    Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
    Date Cleared
    2022-12-15

    (265 days)

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

    Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Small Field Applicator is an accessory to the PROBEAT-V system that is intended to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
    Device Description
    Small Field Applicator is an optional accessory to the proton beam therapy system which can be added to the nozzle configuration of the cleared PROBEAT-V system to make the lateral penumbra sharp, as needed. The Small Field Applicator may be used in place of the optional removable Applicator having an aperture (collimator) that has been cleared as part of the PROBEAT-V system. The Small Field Applicator is composed of a cylinder part with touch sensors, a 4-legged table, and a plate part. The Small Field Applicator is inserted at the end of the nozzle to obtain a sharp lateral penumbra in the lateral dose distribution, and it can reduce the dose to the surrounding normal tissue than the case in which the Small Field Applicator is not used.
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