BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    EW10-EC02 Endoscopy Support Program

    K Number: K230751 · Decision Dec 15, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    19
    Applicant Total
    64
    Review Days
    273

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    Basic Information

    Device Name
    EW10-EC02 Endoscopy Support Program
    K Number
    K230751
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1520
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fujifilm Corporation
    Date Received
    March 17, 2023
    Decision Date
    December 15, 2023
    Product Code
    QNP
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QNP Gastrointesinal Lesion Software Detection System

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