BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    PreXion3D Excelsior

    Reg #: 3009259056 · FEI: 3009259056 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PREXION CORPORATION
    Registration Number
    3009259056
    FEI Number
    3009259056
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1-14-1, Kandasuda-cho
    City
    Chiyoda-ku Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K181983

    Owner / Operator

    Firm Name
    PreXion Corporation
    Operator Number
    10052846
    Address
    1-14-1, Kandasuda-cho
    City
    Chiyoda-ku
    State
    Tokyo
    Postal Code
    101-0041
    Country
    JP
    Correspondent
    Kenji Tanaka

    US Agent

    Business Name
    PreXion,Inc.
    Contact Name
    Keith Huang
    Address
    181 Metro Drive, Suite 190
    City
    San Jose
    State
    CA
    ZIP
    95110
    Country
    US
    Email
    [email protected]
    Phone
    650 2120300

    Products

    Device Name Product Code
    X-Ray, Tomography, Computed, Dental OAS

    Proprietary Names

    PreXion3D Excelsior

    Establishment Types

    Manufacture Medical Device