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510(k) Data Aggregation

    K Number
    K141010
    Device Name
    M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV DIAGNOSTIC ULTRASOUND SYSTEM
    Manufacturer
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS., CO. LTD
    Date Cleared
    2014-05-14

    (26 days)

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

    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS., CO. LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The M9/M9CV/M9T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, trans-esoph.(Cardiac), peripheral vessel , urology exams.
    Device Description
    M9/M9T/M9CV is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, PW-Mode, PW-Mode, Color-Mode , Power/Dirpower Mode, THI, iScape mode, Color M, Elastography, LVO or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 3.0 MHz to 10.0 MHz.
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