BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Ultra/Phonic Scanning Gel

    K Number: K163026 · Decision Jan 9, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    33
    Applicant Total
    5
    Review Days
    435

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    Basic Information

    Device Name
    Ultra/Phonic Scanning Gel
    K Number
    K163026
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pharmaceutical Innovations, Inc.
    Date Received
    October 31, 2016
    Decision Date
    January 9, 2018
    Product Code
    MUI
    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
    MUI Media, Coupling, Ultrasound

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    Other Clearances by Pharmaceutical Innovations, Inc.

    K Number Device Name
    K163027 Ultra/Phonic Free Conductivity Gel
    K163024 Ultra/Phonic Conductivity Gel
    K163023 Other-Sonic Transmission Gel
    K961222 EVRON GEL