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

    UltraSight Guidance

    K Number: K251416 · Decision Dec 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    224

    Basic Information

    Device Name
    UltraSight Guidance
    K Number
    K251416
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2100
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ultrasight , Ltd.
    Date Received
    May 7, 2025
    Decision Date
    December 17, 2025
    Product Code
    QJU
    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
    QJU Image Acquisition And/Or Optimization Guided By Artificial Intelligence

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