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510(k) Data Aggregation

    K Number
    K190769
    Device Name
    Bladder Scanner (Models: M2, M2-W, M1, M1-W)
    Date Cleared
    2019-05-22

    (57 days)

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

    Suzhou Lischka Medtech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bladder Scanner (Models: M2, M2-W, M1, M1-W) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The M2, M2-W, M1, M1-W 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 M2, M2-W, M1, M1-W Bladder Scanner is intended to be used only by qualified medical professionals.
    Device Description
    The M Series Bladder Scanner manufactured by Suzhou Lischka Medtech Co., Ltd. provides noninvasive volume bladder measurement utilizing real-time ultrasound imaging and measurement. The equipment consists of the main unit, 3D probe (M2, M2-W)/2D probe (M1, M1-W), battery and Charger. It features: - Two Operation Modes: Expert Mode and Easy Mode . - Non-invasive, comfortable, correct, reliable, fast and simple operation . - Printouts with ultrasound images and various parameters through PC software . - . Touch screen keyboard operation - . Voice input and play functions - Multi-language selection . - Information storage • - . Information printing - . built-in battery The difference between these models is that the model of the probe is different. M2, M2-W is 3D probe .M1,M1-W is 2D probe. M2-W, M1-W have WIFI connection function, M2, M1 do not have WIFI connection function.
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