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510(k) Data Aggregation

    K Number
    K250331
    Date Cleared
    2025-09-30

    (237 days)

    Product Code
    Regulation Number
    892.1560
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The "Astrasono A3Pro Bladder Scanner" is B-mode pulsed-echo ultrasound device. It is intended as a handheld battery-operated device. The device projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder volume noninvasively. It is intended to be used only by qualified medical professionals.

    Environments of intended use: Professional medical environments

    The intended patient population: Adult patients who require bladder volume measurement (not applicable to pediatric patients).

    Device Description

    The "Astrasono A3Pro Bladder Scanner" is a hand-held battery-operated device, it provides non-invasive bladder volume measurement utilizing real-time ultrasound imaging.

    The "Astrasono A3Pro Bladder Scanner" measures the bladder volume in the range of 0 – 999 mL.

    There are three scanning modes (all B-modes): Easy Mode, Expert Mode, and Empower Mode:

    • Easy Mode: Under this mode, the screen displays a real-time image of bladder silhouette.
    • Expert Mode: Under this mode, the screen displays a real-time image of bladder.
    • Empower Mode: Under this mode, the screen displays a real-time image of bladder projection.

    This device consists of a console (including a rechargeable Li-ion battery pack and built-in printer), a probe, and a medical switching power supply.

    The obtained ultrasound images and calculated bladder volume results can be downloaded to USB drive as encrypted Data.

    AI/ML Overview

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