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

    MODIFICARION TO WACKERS-LIU CQ SOFTWARE

    K Number: K032500 · Decision Aug 25, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    459
    Applicant Total
    2
    Review Days
    12

    Basic Information

    Device Name
    MODIFICARION TO WACKERS-LIU CQ SOFTWARE
    K Number
    K032500
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ECLIPSE SYSTEMS, INC.
    Date Received
    August 13, 2003
    Decision Date
    August 25, 2003
    Product Code
    KPS
    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
    KPS System, Tomography, Computed, Emission

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    Other Clearances by ECLIPSE SYSTEMS, INC.

    K Number Device Name
    K002229 WACKERS-LIU CQ SOFTWARE