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510(k) Data Aggregation

    K Number
    K211886
    Device Name
    Clivia series Diagnostic Ultrasound System
    Manufacturer
    Shenzhen Wisonic Medical Technology Co.Ltd.
    Date Cleared
    2021-12-02

    (164 days)

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

    Shenzhen Wisonic Medical Technology Co.Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Clivia series Diagnostic Ultrasound System is applicable for adults, pediatric patients and neonates. It intended for use in Fetal/Obstetrics, Abdominal/GYN, Pediatrics, Small Organ(breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Musculoskeletal (Conventional), Musculoskeletal (Superticial), Thoracic/Pleural, Cardiac Adult, Cardiac Pediatric), peripheral vessel and Urology exams. The operator for Clivia series Diagnostic Ultrasound System is intended for professional clinical staff or the qualified and trained personnel with experience in the use of ultrasound diagnostic equipment. The device is intended to be used in hospital or clinics. Modes of operation include: B-Mode, Color Mode, Power (Dirpower)-Mode, PW Doppler Mode, CW Doppler Mode, 3D/4D, Holo PW, Tissue Harmonic Imaging, Tissue Doppler Imaging(TDI), Anatomic M(AMM) and combined mode.
    Device Description
    The proposed Clivia series Diagnostic Ultrasound System is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement and analysis of the human body and fluid that provides digital acquisition, processing and display capabilities. The Clivia series Diagnostic Ultrasound System can be controlled both by touch screen or the control panel. Its basic function is to acquire and display ultrasound data in B-Mode, M-Mode, Color-Mode, Power(Dirpower)-Mode, PW-Mode, 3D/4D, Holo PW, Anatomic M(AMM), Tissue Doppler Imaging(TDI) and the combined modes. The system can also measure anatomical structures and offer software analysis packages performance to provide information based on which the competent health care professionals can make the diagnosis. Ten different models of probes are available for the Clivia series, that is C6-1B-H, C6-2-H, C9-3-H, L15-4NB-H, L22-10-H, LH15-6-H, SP5-1-H, P8-3-H, EV11-3-H, D7-2-H. The Clivia series Diagnostic Ultrasound System has the capability for displaying the patient's ECG and trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal. ECG is not intended for monitoring or diagnosis. The Clivia series Diagnostic Ultrasound System has four batteries in total that allows for scanning or other operation without the need to plug in to an electrical outlet. The system is capable of wireless communication and a barcode reader is available to be used as an input device. System meets DICOM requirements to support users image storage and archiving needs and allows for output to printing devices.
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