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

    ContaCT

    K Number: DEN170073 · Decision Feb 13, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    85
    Applicant Total
    1
    Review Days
    137

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    Basic Information

    Device Name
    ContaCT
    K Number
    DEN170073
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    892.2080
    Medical Specialty
    Radiology
    Decision
    Unknown
    Applicant
    Viz.Al, Inc.
    Date Received
    September 29, 2017
    Decision Date
    February 13, 2018
    Product Code
    QAS
    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
    QAS Radiological Computer-Assisted Triage And Notification Software

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