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    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    Aura DR 43C-AG flat panel detector

    K Number: K151014 · Decision Jul 13, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    422
    Applicant Total
    1
    Review Days
    88

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    Basic Information

    Device Name
    Aura DR 43C-AG flat panel detector
    K Number
    K151014
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abyzr Co., Ltd.
    Date Received
    April 16, 2015
    Decision Date
    July 13, 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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