BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY

    K Number: K042605 · Decision Oct 8, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    3
    Applicant Total
    31
    Review Days
    14

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    Basic Information

    Device Name
    COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
    K Number
    K042605
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens AG Medical Solutions
    Date Received
    September 24, 2004
    Decision Date
    October 8, 2004
    Product Code
    NWE
    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
    NWE Colon Computed Tomography System, Computer Aided Detection

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