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510(k) Data Aggregation

    K Number
    K241554
    Device Name
    Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)
    Date Cleared
    2024-10-24

    (146 days)

    Product Code
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Telefield Medical Imaging (Shenzhen) Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Portable Digital Color Doppler Ultrasound System is intended for ultrasound imaging in B (2D), Color Doppler and Pulsed Wave imaging modes. It is indicated for ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Small Organ, Musculoskeletal, Peripheral Vessel, Urology, and Carotid. The Portable Digital Color Doppler Ultrasound System is intended for use in environments where healthcare is provided by appropriately trained and qualified healthcare professionals.
    Device Description
    The Portable Digital Color Doppler Ultrasound System is a portable, general-purpose, software-controlled ultrasound system. It consists of a handheld ultrasound main unit and software. The system is engineered to produce real-time ultrasound images, with an emphasis on capturing detailed anatomical structures and evaluating blood flow patterns using color Doppler technology. It includes features for measurements, image storage and review, as well as printing and recording capabilities. This portable system enables point-of-care ultrasound applications, providing healthcare professionals with a convenient way to visualize anatomical structures and assess blood flow dynamics.
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