Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K221568
    Device Name
    KOLO Evolution XHD Series Ultrasound Diagnostic System
    Date Cleared
    2022-09-12

    (104 days)

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

    Kolo Medical (Suzhou) Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Evolution XHD Series Ultrasound Diagnostic System is a high frequency general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment. The systems support the following clinical applications: The Evolution XHD Series Diagnostic Ultrasound System is applicable for adult and pediatric. It is intended for use in Pediatric, Small parts (breast, thyroid, testicles, prostate), Peripheral vessel, Dermatological, Musculoskeletal (conventional), Musculoskeletal (superficial). Modes of operation include: B Mode, Color Doppler, Power Doppler, Combined modes: B+Color Doppler, B+Power Doppler, B+PW Doppler.
    Device Description
    The Evolution XHD Series device is a high frequency general purpose, software controlled, diagnostic imaging system used to acquire and display high-resolution, real-time ultrasound data. The Evolution XHD Series device is comprised of transducers responsible for ultrasound signal generation, and a main unit that controls the transducers, processes the acoustic data, and processes and displays images. The main unit is a laptop ultrasound console with integrated keyboard, a color video LCD type display and operates from an integrated battery or separate power supply/charger. Evolution XHD Ultrasound Diagnostic System integrated 4 linear probe transducers: L22-8 K2, L28-12K2, L38-22K2, L62-38K2.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1