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

    DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA

    K Number: K093640 · Decision Apr 29, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    13
    Applicant Total
    1
    Review Days
    521

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    Basic Information

    Device Name
    DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA
    K Number
    K093640
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1630
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Electron Jsco.
    Date Received
    November 24, 2009
    Decision Date
    April 29, 2011
    Product Code
    IXK
    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
    IXK System, Imaging, X-Ray, Electrostatic

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