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

    DPX-L AND DPX-ALPHA, MODIFICATION

    K Number: K904980 · Decision Dec 5, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    144
    Applicant Total
    6
    Review Days
    33

    Basic Information

    Device Name
    DPX-L AND DPX-ALPHA, MODIFICATION
    K Number
    K904980
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1170
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    LUNAR
    Date Received
    November 2, 1990
    Decision Date
    December 5, 1990
    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
    K915535 FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOM
    K905291 LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHA
    K890121 MODIFIED DPX BONE DENSITOMETER
    K884625 DPX BONE DENSITOMETER FOR TOTAL BODY BONE DENSITY