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510(k) Data Aggregation

    K Number
    K131227
    Device Name
    PADSCAN HD SERIES BLADDER SCANNER
    Date Cleared
    2013-07-12

    (73 days)

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

    CARENOSO TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PadScan HD series Bladder Scanner is B-mode pulsed-echo ultrasound device. It is intended as a portable battery-operated device. The PadScan HD series 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 HD series Bladder Scanner is intended to be used only by qualified medical professionals.
    Device Description
    The PadScan HD series Bladder Scanner manufactured by Caresono Technology 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 Easy operating mode. . - Correct, reliable, fast, and simple operation. ● - Printouts of ultrasound images with many parameters. ● - . Portable - . Combined power supply with AC adapter and a built-in battery.
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