BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Dolphin/IQ, Dolphin/4D and Dolphin/MAX

    K Number: K191023 · Decision May 16, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    6
    Review Days
    29

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    Basic Information

    Device Name
    Dolphin/IQ, Dolphin/4D and Dolphin/MAX
    K Number
    K191023
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Viasonix , Ltd.
    Date Received
    April 17, 2019
    Decision Date
    May 16, 2019
    Product Code
    IYN
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IYN System, Imaging, Pulsed Doppler, Ultrasonic

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    Other Clearances by Viasonix , Ltd.

    K Number Device Name
    K242662 Falcon/Xpress (Falcon/Xpress)
    K202742 Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory
    K192607 LiteWalk
    K170859 Dolphin/IQ and Dolphin/4D
    K111416 FALCON