BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System

    Reg #: 9614698 · FEI: 3002808382 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    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
    K233195

    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
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System

    Establishment Types

    Manufacture Medical Device