BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    HITACHI HIGH-TECH CORP., KASHIWANOHA

    Reg #: 1000162206 · FEI: 1000162206 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    15
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    HITACHI HIGH-TECH CORP., KASHIWANOHA
    Registration Number
    1000162206
    FEI Number
    1000162206
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    226-44-141-1, WAKASHIBA
    City
    KASHIWA-SHI Chiba
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K152207

    Owner / Operator

    Firm Name
    HITACHI HIGH-TECH CORP.
    Operator Number
    9049564
    Address
    1-17-1 Toranomon,, --
    City
    Minato-ku
    State
    Tokyo
    Postal Code
    105-6409
    Country
    JP

    US Agent

    Business Name
    HITACHI HIGH-TECH AMERICA, INC. RADIATION THERAPY DIVISION
    Contact Name
    Yuki Terakado
    Address
    2535 Augustine Dr
    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
    Accelerator, Linear, Medical IYE

    Proprietary Names

    EXTENDED RANGE SHIFTER FOR PROBEAT-V Small Field Applicator MHI-TM2000 Linear Accelerator System, VERO, Imavis PROBEAT-CR PROBEAT-V PROTON BEAM THERAPY SYSTEM WITH X-RAY LIMITING ACCESSORY PROBEAT-V MHI-TM2000 LINEAR ACCELERATOR SYSTEM PROBEAT WITH MGCS PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM PROBEAT-FR PROBEAT Mini Ridge Filter and auxiliary functions for PROBEAT-V MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS Real Time Image Gating System for Proton Beam Therapy Systems PROBEAT-V AND ACCESSORIES

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198