BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Alphenix INFX-800H/B v8

    Reg #: 9614698 · FEI: 3002808382 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Canon Medical Systems Corporation
    Registration Number
    9614698
    FEI Number
    3002808382
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1385, SHIMOISHIGAMI
    City
    OTAWARA-SHI Tochigi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K182546

    Owner / Operator

    Firm Name
    Canon Medical Systems Corporation
    Operator Number
    9021336
    Address
    1385, SHIMOISHIGAMI, --
    City
    OTAWARA-SHI, TOCHIGI
    State
    JP-NOTA
    Postal Code
    324-8550
    Country
    JP

    US Agent

    Business Name
    Canon Medical Systems USA, Inc.
    Contact Name
    Orlando Tadeo
    Address
    2441 Michelle Dr.
    City
    Tustin
    State
    CA
    ZIP
    92780
    Country
    US
    Email
    [email protected]
    Phone
    714 7305000 ext. 7459

    Products

    Device Name Product Code
    Interventional Fluoroscopic X-Ray System OWB

    Proprietary Names

    Alphenix INFX-800H/B v8

    Establishment Types

    Manufacture Medical Device