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510(k) Data Aggregation

    K Number
    K231989
    Device Name
    LOGIQ E10s, LOGIQ Fortis
    Manufacturer
    GE Medical Systems Ultrasound and Primary Care Diagnostic,
    Date Cleared
    2023-11-07

    (125 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE Medical Systems Ultrasound and Primary Care Diagnostic,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LOGIQ E10s and LOGIQ Fortis are intended for use by a qualified physician for ultrasound evaluation. Specific clinical applications and exam types include: 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, 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 E10s and LOGIQ Fortis are intended to be used in a hospital or medical clinic.
    Device Description
    The LOGIQ E10s is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 585 mm wide (keyboard), 991 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 12-inch high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor. The LOGIQ Fortis is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 575 mm wide (keyboard). 925 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a digital keyboard (physical keyboard as an option), specialized controls, 12inch high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor (or 23.8inch High Resolution LED LCD monitor as an option).
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    K Number
    K232186
    Device Name
    LOGIQ e
    Manufacturer
    GE Medical Systems Ultrasound and Primary Care Diagnostic,
    Date Cleared
    2023-11-03

    (102 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE Medical Systems Ultrasound and Primary Care Diagnostic,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LOGIQ e is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. LOGIQ e is intended to be used in a hospital or medical clinic. LOGIQ e clinical application include: Ophthalmic, fetal/ob; abdominal (gyn & urology); pediatric; small organ (breast, testes, thyroid); neonatal and adult cephalic; cardiac (adult & pediatric); peripheral vascular; musculoskeletal conventional & superficial; transrectal; transvaginal; transesophageal; intraoperative (abdominal, thoracic and peripheral); thoracic/pleural for motion and fluid detection and imaging guidance of interventional procedures (e.g. Nerve block; vascular access). Mode of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/PWD, B/Color/PWD, B/Power/PWD.
    Device Description
    The proposed LOGIQ e system is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement, display and analysis of the human body and fluid. It is an ultrasound imaging & analysis system, consisting of a compact console with LCD, and control panel with new keyboard. The system has digital acquisition, processing and display capability and operates from an integrated battery or AC/DC power adapter. It has one battery pack as standard configuration and also with an optional battery pack to be provided for additional power for longer scanning time. The system also has an optional height-adjustable cart for comfortable standing and sitting positions. The cart is approx. 510mm length, 510mm width and adjustable height from 830 to 1130mm with optional battery box consisting of a charger box and 4pcs battery Packs to supply the system power from the cart. LOGIQ e utilizes a variety of electronic array transducers operating in linear, curved, sector/phased array, TEE. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection. The system supports electronic delivery of software. The system allows the user, in addition to service personnel, to update the SW by logging into a GEHC website to download SW available to them and install it on the system. Download from the GEHC website requires an account.
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