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

    GE LUNAR VISCERAL FAT SOFTWARE

    K Number: K103730 · Decision May 6, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    144
    Applicant Total
    7
    Review Days
    136

    Basic Information

    Device Name
    GE LUNAR VISCERAL FAT SOFTWARE
    K Number
    K103730
    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 ULTRASOUND AND PRIMARY CARE DIA
    Date Received
    December 21, 2010
    Decision Date
    May 6, 2011
    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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