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

    Paragon 2

    K Number: K162687 · Decision Oct 21, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    235
    Applicant Total
    6
    Review Days
    24

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    Basic Information

    Device Name
    Paragon 2
    K Number
    K162687
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1720
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Meridian Medical Systems, LLC
    Date Received
    September 27, 2016
    Decision Date
    October 21, 2016
    Product Code
    IZL
    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
    IZL System, X-Ray, Mobile

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    Other Clearances by Meridian Medical Systems, LLC

    K Number Device Name
    K143232 Universal Digital Interface 2W, UDI 2W
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    K112527 UNIVERSAL DIGITAL INTERFACE (UDI) 1717
    K111305 UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417W
    K103599 UNIVERSAL DIGITAL INTERFACE (UDI) 1717