BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    XV5 Diagnostic Ultrasound System

    Reg #: 8041160 · FEI: 3010289997 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    SAMSUNG MEDISON CO., LTD.
    Registration Number
    8041160
    FEI Number
    3010289997
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3366, Hanseo-ro, Nam-myeon
    City
    HONGCHEON-GUN Gangwon
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K242511

    Owner / Operator

    Firm Name
    SAMSUNG MEDISON CO., LTD.
    Operator Number
    8041160
    Address
    3366, Hanseo-ro, Nam-myeon,
    City
    Hongcheon-gun
    State
    Gangwon
    Postal Code
    25108
    Country
    KR
    Correspondent
    Lisa Jang

    US Agent

    Business Name
    NEUROLOGICA CORPORATION
    Contact Name
    Ninad Gujar
    Address
    14 Electronics Ave
    City
    Danvers
    State
    MA
    ZIP
    01923
    Country
    US
    Email
    [email protected]
    Phone
    978 5648632

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    XV5 Diagnostic Ultrasound System V4 Diagnostic Ultrasound System V5 Diagnostic Ultrasound System XV4 Diagnostic Ultrasound System XH4 Diagnostic Ultrasound System XH5 Diagnostic Ultrasound System H4 Diagnostic Ultrasound System H5 Diagnostic Ultrasound System

    Establishment Types

    Manufacture Medical Device