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510(k) Data Aggregation

    K Number
    K250791

    Validate with FDA (Live)

    Device Name
    ASUS Ultrasound Imaging System (LU800 series)
    Manufacturer
    Asustek Computer, Inc.
    Date Cleared
    2025-12-04

    (265 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Age Range
    0 - 150
    Reference & Predicate Devices
    K222365
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ASUS Ultrasound Imaging System (Model: LU800 Series) is a software-based imaging system and accessories intended for use by qualified and trained healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body.

    The modes of operation include B mode, M mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode (B+M, B+CD, B+PWD). Specific clinical applications and exam types including:

    LU800L
    General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Neonatal cephalic, Musculoskeletal (conventional), Musculoskeletal (superficial), Peripheral vessel, Other(Carotid), Pulmonary, interventional guidance(includes free hand needle/ catheter)

    LU800C
    Fetal, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Urology, Musculoskeletal (conventional), OB/Gyn, Cardiac (adult), Cardiac(pediatric), Peripheral vessel, interventional guidance(includes free hand needle/ catheter)

    LU800M
    Fetal, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Neonatal cephalic, Urology, Musculoskeletal (conventional), OB/Gyn, Cardiac(adult), Cardiac (pediatric), Peripheral vessel

    LU800PA
    Fetal, General abdominal imaging, Pediatric, Cardiac (adult), Cardiac (pediatric), Pulmonary

    LU800E
    Fetal, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Trans-rectal, Trans-vaginal, Urology, OB/Gyn, interventional guidance(includes free hand needle/ catheter)

    The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients.

    Device Description

    The ASUS Ultrasound Imaging System (Model: LU800 Series) is a portable, software controlled, handheld ultrasound system used to acquire and display hi-resolution, real-time ultrasound data through a commercial off-the-shelf (COTS) mobile device.

    I. The imaging system software runs as an app on a mobile device.

    II. The imaging system software can be download to a commercial off-the-shelf (COTS) mobile device and utilizes an icon touch-based user interface.

    III. The imaging system consists of a series of wireless transducers employing Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range portable personal device.

    IV. The imaging system houses a built-in battery, multichannel beamformer, prescan converter and Wi-Fi components

    The device is intended for use in environments where healthcare is provided by qualified and trained healthcare professionals, but not intended for use in emergency medical service, ambulance, or aircraft.

    AI/ML Overview

    N/A

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