BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR

    K Number: K092907 · Decision Mar 5, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    11
    Review Days
    164

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    Basic Information

    Device Name
    DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR
    K Number
    K092907
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shantou Institute of Ultrasonic Instuments
    Date Received
    September 22, 2009
    Decision Date
    March 5, 2010
    Product Code
    IYN
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IYN System, Imaging, Pulsed Doppler, Ultrasonic

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    Other Clearances by Shantou Institute of Ultrasonic Instuments

    K Number Device Name
    K113613 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM
    K081110 SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM
    K070982 CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM
    K061083 CTS-7700
    K013327 CTS-415
    K012772 CTS-485 ULTRASOUND IMAGING SYSTEM
    K984203 SIUI APOGEE 800PLUS ULTRASOUND IMAGING SYSTEM
    K984161 CTS-310(B)
    K963065 CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS
    K963068 CTS-200 WITH EZU-PL21 TRANSDUCER
    Search all 11 clearances from Shantou Institute of Ultrasonic Instuments →