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510(k) Data Aggregation

    K Number
    K183041
    Device Name
    Full Digital Colour Doppler Ultrasonic Diagnostic System
    Date Cleared
    2019-07-10

    (251 days)

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

    Wuhan Zoncare Bio-medical Electronics Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ZONCARE-M5 Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include: Abdominal Gynecology(including endovaginal) Obstetric Cardiac Small parts(Breast,Testes,Thyroid,etc.) Urology Musculoskeletal Peripheral vascular
    Device Description
    The ZONCARE-M5 Ultrasound system consists of a main system along with associated transducers. The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The waves are then reflected within the body and detected by the transducer, which then converts back to an electrical signal. The ZONCARE-M5 system then analyzes the returned signal to generate an image or conduct Doppler processing. The ZONCARE-M5 system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis. The system provides hardware buttons for the User Interface.
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