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

    Universal Digital Interface 2W, UDI 2W

    K Number: K143232 · Decision Jan 30, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    422
    Applicant Total
    6
    Review Days
    81

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    Basic Information

    Device Name
    Universal Digital Interface 2W, UDI 2W
    K Number
    K143232
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Meridian Medical Systems, LLC
    Date Received
    November 10, 2014
    Decision Date
    January 30, 2015
    Product Code
    MQB
    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
    MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

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    Other Clearances by Meridian Medical Systems, LLC

    K Number Device Name
    K162687 Paragon 2
    K140251 UNIVERSAL DIGITAL INTERFACE 2, UDI 2
    K112527 UNIVERSAL DIGITAL INTERFACE (UDI) 1717
    K111305 UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417W
    K103599 UNIVERSAL DIGITAL INTERFACE (UDI) 1717