BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HITACHI HIGH-TECH AMERICA, INC. RADIATION THERAPY DIVISION

    Reg #: 3003993895 · FEI: 3003993895 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HITACHI HIGH-TECH AMERICA, INC. RADIATION THERAPY DIVISION
    Registration Number
    3003993895
    FEI Number
    3003993895
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2535 Augustine Dr
    City
    Santa Clara
    State
    CA
    ZIP
    95054
    Country
    US

    Regulatory Submissions

    510(k) Number
    K053280

    Owner / Operator

    Firm Name
    Hitachi High-Tech America, Inc. Radiation Therapy Division
    Operator Number
    10094162
    Address
    2535 Augustine Dr.
    City
    Santa Clara
    State
    CA
    Postal Code
    95054
    Country
    US
    Correspondent
    Yuki Terakado

    Products

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

    Proprietary Names

    PROBEAT

    Establishment Types

    Manufacture Medical Device