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

    MINXRAY, MODELS HFP24 AND HFP40

    K Number: K060566 · Decision Apr 5, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    235
    Applicant Total
    1
    Review Days
    33

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    Basic Information

    Device Name
    MINXRAY, MODELS HFP24 AND HFP40
    K Number
    K060566
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1720
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mikasa X-Ray Co., Ltd.
    Date Received
    March 3, 2006
    Decision Date
    April 5, 2006
    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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