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

    Synapse Lung Nodule AI

    K Number: K254075 · Decision May 27, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    19
    Applicant Total
    64
    Review Days
    160

    Basic Information

    Device Name
    Synapse Lung Nodule AI
    K Number
    K254075
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fujifilm Corporation
    Date Received
    December 18, 2025
    Decision Date
    May 27, 2026
    Product Code
    OEB
    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
    OEB Lung Computed Tomography System, Computer-Aided Detection

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