BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Viasonix Ltd.

    Reg #: 3009286597 · FEI: 3009286597 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    Viasonix Ltd.
    Registration Number
    3009286597
    FEI Number
    3009286597
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    9 Dafna St.
    City
    RAANANA Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K191023

    Owner / Operator

    Firm Name
    VIASONIX LTD
    Operator Number
    10038161
    Address
    10 Hamelacha Street
    City
    Raanana
    State
    IL-NOTA
    Postal Code
    43661
    Country
    IL
    Correspondent
    Dan Manor

    US Agent

    Business Name
    Image Monitoring USA Inc.
    Contact Name
    Tanya Tomlinson
    Address
    173 Dingens St.
    City
    Buffalo
    State
    NY
    ZIP
    14206
    Country
    US
    Email
    [email protected]
    Phone
    716 8533703

    Products

    Device Name Product Code
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    Massager, Powered Inflatable Tube IRP
    Diagnostic Ultrasonic Transducer, Robotic OQQ
    Transducer, Ultrasonic JOP

    Proprietary Names

    Dolphin/IQ, Dolphin/4D and Dolphin/MAX LiteWalk Dolphin/IQ, Dolphin/4D, Dolphin/Xpress and Dolphin/MAX with Dolphin/XF Robot Accessory Dolphin IQ and Dolphin/4D FALCON/PRO, FALCON/QUAD, FALCON/ABI Falcon/Xpress

    Establishment Types

    Manufacture Medical Device