BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)

    K Number: K253163 · Decision Apr 22, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    85
    Applicant Total
    15
    Review Days
    208

    Basic Information

    Device Name
    EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)
    K Number
    K253163
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2080
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ever Fortune.Ai, Co., Ltd.
    Date Received
    September 26, 2025
    Decision Date
    April 22, 2026
    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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