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

    syngo.CT Lung CAD (Version VD30)

    K Number: K231157 · Decision Jul 19, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    19
    Applicant Total
    31
    Review Days
    86

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    Basic Information

    Device Name
    syngo.CT Lung CAD (Version VD30)
    K Number
    K231157
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare GmbH
    Date Received
    April 24, 2023
    Decision Date
    July 19, 2023
    Product Code
    OEB
    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
    OEB Lung Computed Tomography System, Computer-Aided Detection

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