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510(k) Data Aggregation

    K Number
    K230160
    Device Name
    VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86, VINNO M86E,VINNO G90,VINNO G90E
    Date Cleared
    2023-06-23

    (155 days)

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

    Vinno Technology (Suzhou) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended for ultrasound imaging, measurement, display and analysis of the human body and fluid. The operating modes supported by the device are B, M.PWD CWD, Tissue Doppler, Color Doppler, Power Doppler, Tissue Velocity Imaging, Harmonic Imaging, 3D/4D, Combine modes. This device is indicated for Abdominal; Fetal/Obstetrics; Gynecology; Transvagmal; Urology(including prostate); Trans rectal; Cardiac(adult and child); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle), Musculoskeletal(Conventional and Superficial); Pediatrics(including neonatal cephalic); interventional(nerve block and vascular access); Intraoperative (abdominal, brain) and Adult Cephalic diagnostic Ultrasound applications. This device is intended to use by, or by the order of, and under the supervision of an appropriately-trained healtheare professional qualified to direct the use of the device in hospitals or clinics.
    Device Description
    VINNO G86,VINNO G86E, VINNO M86E, VINNO G65, VINNO G65, VINNO G65E, VINNO G65D, VINNO G65D, VINNO G90, VINNO G90E ultrasound devices are professional digital color ultrasonic apparatus.It transmits ultrasound waves into the body tissues and displays the echo images of the tissues and blood flow accordingly.
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    K Number
    K190120
    Device Name
    VINNO 8, VINNO 6, VINNO 5
    Date Cleared
    2020-01-23

    (364 days)

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

    VINNO Technology (Suzhou) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is general purpose diagnostic ultrasound system for use by qualified healthcare professionals. It is applicable for adults, pregnant women, pediatric patients and neonates. The device is intended for ultrasound imaging, measurement and analysis of human body and fluid for multiple clinical applications including: abdominal (GYN and Urology), Thoracic/Pleural, Fetal/Ob, small organ (including breast, thyroid, testes), peripheral vessel, neonatal cephalic, pediatric, musculo-skeletal (conventional, superficial), transrectal, trans-vaginal, cardiac adult, cardiatric, magnetic Needle guidance and imaging guidance of interventional procedures (e.g. biopsy). This device is intended to use by, or by the order of, and under the supervision of a licensed physician qualified to direct the use of the device. The device is used in hospital, clinics and clinical point-of-care for diagnosis of patients.
    Device Description
    The VINNO 8, VINNO 6, VINNO 5 ultrasound devices are laptop digital color ultrasonic diagnostic devices which transmit ultrasound waves into the body tissues and display the echo images of the tissues and blood flow accordingly. The devices are capable of digital acquisition, processing and display and operate from an integrated battery or separate power supply/charger. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. The VGuide NGS function detects the position and orientation of magnetized needles in the presence of the probe and displays this information relative to the ultrasound image. Spatial positioning of the needle, with respect to the ultrasound image, is then updated in real time. This guides the operator to better visualize the needle in the ultrasound image during ultrasound guided needling procedures.
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