BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    SpotLight/SpotLight Duo (with DLIR option)

    K Number: K230370 · Decision Oct 13, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    818
    Applicant Total
    5
    Review Days
    245

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    Basic Information

    Device Name
    SpotLight/SpotLight Duo (with DLIR option)
    K Number
    K230370
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arineta , Ltd.
    Date Received
    February 10, 2023
    Decision Date
    October 13, 2023
    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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