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

    GE LUNAR BODY COMPOSITION SOFTWARE

    K Number: K071570 · Decision Jun 27, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    146
    Applicant Total
    2
    Review Days
    19

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    Basic Information

    Device Name
    GE LUNAR BODY COMPOSITION SOFTWARE
    K Number
    K071570
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1170
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ge Medical Systems Lunar
    Date Received
    June 8, 2007
    Decision Date
    June 27, 2007
    Product Code
    KGI
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    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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    Other Clearances by Ge Medical Systems Lunar

    K Number Device Name
    K113286 ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS