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510(k) Data Aggregation

    K Number
    K231509
    Device Name
    Aco Apache Ultrasound System
    Date Cleared
    2023-10-24

    (152 days)

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

    Aco Healthcare Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Apache Ultrasound System is intended for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Fetal/Obstetric, Gynecological, Fetal Echo, Musculo-skeletal (conventional and superficial), Small Organ (including breast, scrotum, thyroid), Cephalic (adult), Peripheral Vessel, Carotid, Urology, FAST/EFAST, Lung, Ocular, Nerve, Cardiac (Pediatric and Adult) and Pediatric. The system provides diaging in B, Color Doppler, M, Power Doppler and Combined (B+M; B+CD ; B+PD) modes. The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point of care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high. The Apache Ultrasound System is a portable ultrasound system intended for use in environments where is provided by trained healthcare professionals.
    Device Description
    The Aco Apache Ultrasound System is a portable color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications through wireless communication with an off-the-shelf (OTS) mobile device. This system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode, M-Mode, Color Doppler mode, Power Doppler mode, PW mode or a combination of these modes. The Apache Probe processes the ultrasound signal and transfers real-time scan image data to the Apache App through the wireless connection with the mobile device. The 64-channel beamforming architecture of the probe maximizes the utility of all imaging transducer elements to enhance the diagnostic utility and confidence provided by the system. The Apache App provides the interface for mode/setting control and image display, acquisition, and storage functions. The Apache App is compatible with Android and iOS based mobile devices. Verified devices include Samsung Galaxy Tab S6, Samsung Galaxy Tab S6 Lite, Samsung Galaxy Tab S7, Samsung Galaxy Tab S7 FE, Samsung Galaxy Tab S8, Samsung Galaxy S10, Samsung Galaxy S21, Xiaomi Pad 5, Google Pixel 4, Google Pixel 6, HTC U11, LG G85 ThinQ, iPhone 11, iPhone 12, iPhone 14, iPad Pro 11-inch (Gen2), iPad Air (Gen4), iPad Air (Gen5), iPad 9. The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high.
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