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510(k) Data Aggregation

    K Number
    K153581
    Device Name
    Bladder Scanner
    Date Cleared
    2016-04-08

    (115 days)

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

    Caresono Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bladder Scanner(model: PadScan HD2) is B-mode pulsed-echo ultrasound device. It intended as a handheld batteryoperated device. The PadScan HD2 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 PadScan HD2 Bladder Scanner is intended to be used only by qualified medical professionals.
    Device Description
    The PadScan HD2 Bladder Scanner manufactured by Caresono Technology provides real-time ultrasound imaging and measuring, and also provides non-invasive volume measurement of the bladder. It is a handheld bladder scanner, the main unit and the probe are all-in-one. It features: - · Expert operating mode and Easy operating mode - · Non-invasive, comfortable, correct, reliable, fast and simple operation - SD card storage - Voice recording function - Urine volume setting and alarm setting - Multi-language selection - · Injection molded shell, the main unit and the probe are all-in-one, 2.5-inch LCD screen(240x320pixels) - Power supply with built-in battery.
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