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

    QCT BONE MINERAL DENSITY ANALYSIS SOFTWARE

    K Number: K894854 · Decision Oct 19, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    146
    Applicant Total
    1
    Review Days
    80

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    Basic Information

    Device Name
    QCT BONE MINERAL DENSITY ANALYSIS SOFTWARE
    K Number
    K894854
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1170
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Image Enhancements
    Date Received
    July 31, 1989
    Decision Date
    October 19, 1989
    Product Code
    KGI
    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
    KGI Densitometer, Bone

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