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

    LOGIQ E10s, LOGIQ Fortis

    K Number: K231989 · Decision Nov 7, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    2
    Review Days
    125

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    Basic Information

    Device Name
    LOGIQ E10s, LOGIQ Fortis
    K Number
    K231989
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ge Medical Systems Ultrasound and Primary Care Diagnostic,
    Date Received
    July 5, 2023
    Decision Date
    November 7, 2023
    Product Code
    IYN
    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
    IYN System, Imaging, Pulsed Doppler, Ultrasonic

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    Other Clearances by Ge Medical Systems Ultrasound and Primary Care Diagnostic,

    K Number Device Name
    K232186 LOGIQ e