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

    DIGITAL FLAT PANEL X-RAY DETECTOR

    K Number: K112558 · Decision Nov 10, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    422
    Applicant Total
    5
    Review Days
    69

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    Basic Information

    Device Name
    DIGITAL FLAT PANEL X-RAY DETECTOR
    K Number
    K112558
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Samsung Mobile Display Co., Ltd.
    Date Received
    September 2, 2011
    Decision Date
    November 10, 2011
    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 Samsung Mobile Display Co., Ltd.

    K Number Device Name
    K112751 SDX-4343CS
    K102321 DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP
    K102587 LLX240AB01
    K090742 DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A