BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    HALO

    K Number: K200873 · Decision Nov 20, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    85
    Applicant Total
    2
    Review Days
    233

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    Basic Information

    Device Name
    HALO
    K Number
    K200873
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2080
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nico-Lab B.V.
    Date Received
    April 1, 2020
    Decision Date
    November 20, 2020
    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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