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510(k) Data Aggregation

    K Number
    K220983
    Device Name
    ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System
    Date Cleared
    2022-11-11

    (221 days)

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

    ImSonic Medical China, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ImSonic TR-1 Ultrasonic pulsed doppler imaging system is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. The system is intended to be used in a hospital or clinic setting. Specific clinical applications and exam types include: Fetal/obstetric Gynecological /Pelvic Abdominal Renal Cardiac Pediatric Small organ (thyroid, breast, testes, etc.) Musculoskeletal (conventional & superficial) Peripheral vascular Ophthalmic Modes of operation include B, M, PWD(PW), Color Doppler (C), B+M, B+Color Doppler, B+PWD, Biopsy, Harmonics (Tissue), Contrast Imaging (CPS), Steered Spatial Compounding (SSC).
    Device Description
    The ImSonic TR-1 is a general purpose, mobile Ultrasonic Pulsed Doppler Imaging System. The function is to acquire ultrasound data and to display in various modes of operation. The device consists of two parts: the system console and the transducers. The system console contains the user interface, a display, a touch screen, a control panel, system electronics and optional peripherals (barcode scanner, printer). The removable transducers are connected to the system using a standard technology, multipin connectors.
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