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

    FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOM

    K Number: K915535 · Decision Feb 27, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    146
    Applicant Total
    6
    Review Days
    80

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    Basic Information

    Device Name
    FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOM
    K Number
    K915535
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1170
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Lunar
    Date Received
    December 9, 1991
    Decision Date
    February 27, 1992
    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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    Other Clearances by Lunar

    K Number Device Name
    K914404 ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESIT
    K905291 LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHA
    K904980 DPX-L AND DPX-ALPHA, MODIFICATION
    K890121 MODIFIED DPX BONE DENSITOMETER
    K884625 DPX BONE DENSITOMETER FOR TOTAL BODY BONE DENSITY