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510(k) Data Aggregation

    K Number
    K223448
    Device Name
    Bladder Scanner Model: BVT02
    Date Cleared
    2023-07-07

    (234 days)

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

    Xuzhou Kaixin Electronic Instrument Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BVT02 Bladder Scanner is B-mode pulsed-echo ultrasound device. It is intended as a portable device. The BVT02 Bladder Scanner projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder volume noninvasively. The BVT02 Bladder Scanner is intended to be used only by qualified medical professionals. Intended use environment: Professional health care facilities.
    Device Description
    The BVT02 Bladder Scanner manufactured by Xuzhou Kaixin Electronic Instrument Co., Ltd. provides real - time ultrasound imaging and measuring, and also provides non invasive volume measurement of the bladder. During image scanning, multiple 2D plane ultrasonic images are acquired in several seconds. It features: Expert operating mode and Lite operating mode. Portable. Combined power supply with AC adapter and a battery.
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