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510(k) Data Aggregation

    K Number
    K211488
    Device Name
    LOGIQ E10
    Manufacturer
    GE Healthcare
    Date Cleared
    2021-09-10

    (120 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K202658,K200158
    Predicate For
    K231966
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    LOGIQ E10 is intended for use by a qualified physician for ultrasound evaluation of Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Abdominal and Vascular).

    Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The LOGIQ E10 is intended to be used in a hospital or medical clinic.

    Device Description

    The LOGIQ E10 is a full featured, track 3, general purpose diagnostic ultrasound system which consists of a mobile console that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, LCD touch screen and color widescreen monitor (OLED and HDU monitors). The system utilizes a variety of linear, curved, phased, dual, and matrix array transducers to support the broad imaging capabilities.

    AI/ML Overview

    The provided text focuses on the 510(k) premarket notification for the GE Healthcare LOGIQ E10 ultrasound system. It primarily discusses the device's indications for use, its technical characteristics, and its comparison to predicate devices to demonstrate substantial equivalence.

    Crucially, the document explicitly states in the "Summary of Clinical Tests" section:

    "The subject of this premarket submission, LOGIQ E10, did not require clinical studies to support substantial equivalence."

    This statement means that the information requested regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment is not available within this document, as no clinical studies were performed or required for this 510(k) submission.

    Therefore, I cannot provide the detailed information requested in your prompt based solely on the provided text. The document's purpose is to demonstrate substantial equivalence to a legally marketed predicate device through non-clinical data, rather than presenting a clinical study of the device's efficacy or performance against specific clinical acceptance criteria.

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