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510(k) Data Aggregation

    K Number
    K213488
    Device Name
    Bladder Scanner, Model Name:M5
    Date Cleared
    2022-07-01

    (242 days)

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

    Suzhou Peaksonic Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bladder Scanner (Model Name:MS) is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease. Mode of operation: B-mode. Intended user population: Trained and qualified healthcare professionals. Intended use environment:Professional health care facilities.
    Device Description
    The Bladder Scanner (model:M5) designed and manufactured by SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO., LTD. is a kind of B mode noninvasive bladder volume measurement and bladder wall thickness measurement based on ultrasonic imaging and measurement principle. The Bladder Scanner (model:M5) is composed of main device, probe, trolley and upper computer software. The main device and probe measure bladder wall thickness, and thickness, and they can transmit the patient information and measurement result to upper computer running upper computer software by WIFI or USB to manage and process patient's data, and the main device include print function.
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