BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    RADspeed Pro

    Reg #: 8030233 · FEI: 3002808139 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
    Registration Number
    8030233
    FEI Number
    3002808139
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1,NISHINOKYO-KUWABARACHO,, NAKAGYOKU
    City
    KYOTO
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K233722

    Owner / Operator

    Firm Name
    Shimadzu Corporation
    Operator Number
    8030233
    Address
    1 NISHINOKYO KUWABARA-CHO
    City
    KYOTO-SHI
    State
    JP-26
    Postal Code
    604-8511
    Country
    JP

    US Agent

    Business Name
    Shimadzu Medical Systems
    Contact Name
    Johnny Goossens
    Address
    3645 N Lakewood Blvd
    City
    Long Beach
    State
    CA
    ZIP
    90808
    Country
    US
    Email
    [email protected]
    Phone
    310 2178855 ext. 174

    Products

    Device Name Product Code
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Stationary KPR

    Proprietary Names

    RADspeed Pro

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device