BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    IC-Flow™ Imaging System 2.0

    K Number: K243645 · Decision Sep 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    198
    Applicant Total
    1
    Review Days
    300

    Basic Information

    Device Name
    IC-Flow™ Imaging System 2.0
    K Number
    K243645
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1600
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diagnostic Green GmbH
    Date Received
    November 26, 2024
    Decision Date
    September 22, 2025
    Product Code
    IZI
    Advisory Committee
    Radiology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IZI System, X-Ray, Angiographic

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