BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    OmniTom Elite with PCD

    K Number: K250928 · Decision Sep 8, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    818
    Applicant Total
    8
    Review Days
    164

    Basic Information

    Device Name
    OmniTom Elite with PCD
    K Number
    K250928
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neurologica Corporation
    Date Received
    March 28, 2025
    Decision Date
    September 8, 2025
    Product Code
    JAK
    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
    JAK System, X-Ray, Tomography, Computed

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