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510(k) Data Aggregation

    K Number
    K242167
    Device Name
    Sterile and Non-Sterile Ultrasonic Coupling Agent
    Manufacturer
    Anhui Deepblue Medical Technology Co.,Ltd.
    Date Cleared
    2024-09-19

    (57 days)

    Product Code
    MUI
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anhui Deepblue Medical Technology Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sterile and Non-Sterile Ultrasonic Coupling Agent are ultrasound couplants intended to be used on intact skin during noninvasive medical ultrasound procedures to cound waves between a patient and the medical imaging electronics. The gels are intended for use in all diagnostic ultrasound procedures which require coupling gel or fluid. The gels can be used during the procedures that involved adults and pediatrics in professional healthcare facility.
    Device Description
    The subject device, Sterile and Non-Sterile Ultrasonic Coupling Agent, are nonirritating, non-sensitizing acoustic couplants intended for use as a scanning gel in medical diagnostic ultrasound procedures. The Ultrasonic Coupling Agent is an accessory used to couple sound waves between the patient and the medical imaging electronic transducers during diagnostic ultrasound procedures. The Ultrasonic Coupling Agent is a type of conductive medium that enables a tight bond between the skin and the probe or transducer, allowing the waves to transmit directly to the tissues beneath and to the parts that need to be imaged. As such, the Ultrasonic Coupling Agent is formulated to improve the acoustic transmission of sound waves to create the ultrasound image.
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