BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Small Field Applicator for PROBEAT-V

    Reg #: 1000162206 · FEI: 1000162206 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HITACHI, LTD. RADIATION ONCOLOGY SYSTEMS, KASHIWANOHA
    Registration Number
    1000162206
    FEI Number
    1000162206
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    226-44-141-1, WAKASHIBA
    City
    KASHIWA-SHI Chiba
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K220883

    Owner / Operator

    Firm Name
    HITACHI, LTD., Healthcare Business Division
    Operator Number
    9064557
    Address
    226-44-141-1, Wakashiba, KOIL TERRACE 3F
    City
    Kashiwa-shi
    State
    Chiba
    Postal Code
    277-0871
    Country
    JP
    Correspondent
    TOMOKO - IRISA

    US Agent

    Business Name
    HITACHI AMERICA, LTD. Particle Therapy Division
    Contact Name
    Yuki Terakado
    Address
    2535 Augustine Drive, 2nd Floor
    City
    Santa Clara
    State
    CA
    ZIP
    95054
    Country
    US
    Email
    [email protected]
    Phone
    408 9866300

    Products

    Device Name Product Code
    System, Radiation Therapy, Charged-Particle, Medical LHN

    Proprietary Names

    Small Field Applicator for PROBEAT-V

    Establishment Types

    Manufacture Medical Device