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510(k) Data Aggregation

    K Number
    K230986
    Device Name
    Bladder Scanner
    Date Cleared
    2023-12-29

    (267 days)

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

    Avantsonic Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bladder Scanner is B-mode pulsed-echo ultrasound device adopts a 3D mechanical fan scanning probe for the ultrasonic scanning for bladder and measures the bladder volume from the abdominal surface of ultrasonic imaging. The Bladder Scanner is intended to be used only in hospital and by qualified medical professionals.
    Device Description
    The Bladder Scanner (Model: AS-2) is a hand-held battery-operated device, it provides non-invasive bladder volume measurement utilizing real-time ultrasound imaging. The proposed device consists of the main unit (include 3D probe), battery power adapter and USB charging cable.
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    K Number
    K171528
    Device Name
    Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)
    Date Cleared
    2018-01-24

    (244 days)

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

    Avantsonic Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bladder Scanner (model: PadScan Z3, PadScan Z3, PadScan Z5) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The 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 Bladder Scanner is intended to be used only by qualified medical professionals.
    Device Description
    The PadScan Series manufactured by AvantSonic Technology Co., Ltd. provides non-invasive volume bladder measurement utilizing real-time ultrasound imaging and measurement. The equipment consists of the main unit, 3D probe, battery and adapter. 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, Urine volume setting and alarm setting, Multi-language selection, Combined power supply with AC adapter and a built-in battery. The difference between these models is the size of the LCD screen and enclosure structure. PadScan DS3 is provided 7-inch LCD screen. PadScan Z3 is provided 7-inch LCD screen and LCD screen stand. PadScan Z5 is provided 8-inch LCD screen and LCD screen which has a handle.
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