BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    COLON CAR 1.2

    K Number: K042674 · Decision Oct 19, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    3
    Applicant Total
    5
    Review Days
    20

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    Basic Information

    Device Name
    COLON CAR 1.2
    K Number
    K042674
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medicsight
    Date Received
    September 29, 2004
    Decision Date
    October 19, 2004
    Product Code
    NWE
    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
    NWE Colon Computed Tomography System, Computer Aided Detection

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