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

    Rapid LVO

    K Number: K200941 · Decision Jul 9, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    69
    Applicant Total
    6
    Review Days
    92

    Basic Information

    Device Name
    Rapid LVO
    K Number
    K200941
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2080
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    iSchemaView Inc.
    Date Received
    April 8, 2020
    Decision Date
    July 9, 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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