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510(k) Data Aggregation

    K Number
    K173486
    Device Name
    NTU-USB Ultrasound USB Box
    Date Cleared
    2018-07-11

    (240 days)

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

    National Taiwan University

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NTU-USB ultrasound USB box is a general ultrasound imaging system intended for use by a qualified physician or sonographer for clinical diagnosis. Specific clinical applications and exam types include: 1. Small Organ (Breast) 2. Peripheral Vessel
    Device Description
    The NTU-USB Ultrasound USB box is a standalone ultrasound system which can perform real-time anatomical imaging of Small Organs/Parts (e.g. Breast) and blood flow measurements of Peripheral Vascular. Users include ultrasound imaging technicians (sonographers) and physicians. The NTU-USB Ultrasound USB box may be used in a hospital (e.g. imaging laboratory, emergency room, patient bedside, operating room), medical clinic, physician's office or a mobile imaging center. The NTU-USB Ultrasound USB box consists of two major components: 1) USB box; and, 2) Transducer. The USB box housed the microprocessor, memory, amplifiers and a power supply for the microprocessor. The USB box performs the calculations involved in processing the data to produce the displayed ultrasound image. The USB box is designed to connect with a Windows x86platform PC/laptop (not included in this product) and a compatible linear transducer. It receives command and display on the UI of the PC/laptop and following sends electrical currents to and receives electrical pulses from the compatible transducer. The system provides qualified physicians with a friendly workflow and sufficient image quality for the following applications: B (2D) mode, ColorDoppler (CD), Pulsed Wave Doppler (PW) mode Available with the system is a Linear array transducer allowing for many clinical applications. Accessories include an AC adaptor and a USB 3.0 cable. Case studies can be stored to USB memory stick, DVD, and other industry standard archiving devices using the connected PC/laptop. The NTU-USB ultrasound USB Box contain the hardware and software which collect and pro-process 'rough' data and send it via USB 3.0 connection to a Windows based PC. The main application software is NTU-USB SW running on the PC, it is receiving data, processing and showing image/data on the screen. The main user interface shows an ultrasound image, controls and drop-out menus. The ultrasound images and calculated/measured data can be stored in memory.
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