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

    Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout

    K Number: K252476 · Decision Oct 16, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    599
    Registration Numbers
    599
    Same Product Code
    2271
    Applicant Total
    135
    Review Days
    70

    Basic Information

    Device Name
    Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
    K Number
    K252476
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Brainlab AG
    Date Received
    August 7, 2025
    Decision Date
    October 16, 2025
    Product Code
    LLZ
    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
    LLZ System, Image Processing, Radiological

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