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510(k) Data Aggregation

    K Number
    K081873
    Device Name
    EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE
    Manufacturer
    SHENZHEN EMPEROR ELECTRONIC TECHNOLOGY CO. LTD.
    Date Cleared
    2008-07-16

    (14 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHENZHEN EMPEROR ELECTRONIC TECHNOLOGY CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EMP-2100 Full Digital Ultrasound Diagnostic System is a general-purpose, digital ultrasound diagnostic system for abdomen, gynecology, obstetric, urology, small-parts, and cardiology application. The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, cardiac, transvaginal, peripheral vascular, and musculo-skeletal(both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate. The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional. This device is not intended for home use.
    Device Description
    EMP-2100 Full Digital Ultrasound Diagnostic Device is a portable digital ultrasonic diagnostic B/W system applied in ultrasound diagnostic examination of abdomen, gynecology, obstetric, urology, small-parts, and cardiology application. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor. The resulting information is displayed in five display modes as listed below. This system is a Track 1 device that employs an array of probes that include linear array, convex linear array and microconvex linear array with a frequency range of approximately 2.5MHz~7.5MHz. The subject device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not provided sterile and the transducer does not need sterilization and the transducer is reusable but does not need re-sterilization. The system consists of a main unit, a display and four transducers.
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