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510(k) Data Aggregation

    K Number
    K110841
    Device Name
    DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED ARRAY TRANSDUCER
    Manufacturer
    SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI
    Date Cleared
    2011-04-15

    (21 days)

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

    SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.
    Device Description
    The SIUI Apogee 3800 is a Digital Ultrasound Imaging System capable of the following operating modes: 2D (B mode), M, Doppler (PWD mode), Color (CFM mode) and 3D. The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array and 3D transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.
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    K Number
    K103144
    Device Name
    DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER
    Manufacturer
    SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI
    Date Cleared
    2011-01-12

    (79 days)

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

    SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organs, musculo-skeletal, cardiac and peripheral vascular applications. Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.
    Device Description
    The SIUI Apogee 1000 is a Digital Ultrasound Imaging System capable of the following operating modes: 2D (B mode), M, Doppler (PWD mode), Color (CFM mode) and 3D. The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array and 3D transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.
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    K Number
    K102023
    Device Name
    DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX ARRAY TRANSDUCER, MODEL C3L60C
    Manufacturer
    SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI
    Date Cleared
    2010-10-19

    (92 days)

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

    SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K101008
    Device Name
    DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY
    Manufacturer
    SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI
    Date Cleared
    2010-06-08

    (57 days)

    Product Code
    ITX, IYN, IYO
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.
    Device Description
    Apogee 1100 Digital Color Doppler Ultrasound Imaging System with Convex Array Transducer C3L60C, Linear Array Transducer L8L38C, Convex Array Transducer C5L40C, Phased Array Transducer P3F14C
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    K Number
    K061488
    Device Name
    CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM
    Manufacturer
    SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI
    Date Cleared
    2006-06-30

    (30 days)

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

    SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organ, cardiac, peripheral vascular applications
    Device Description
    The SIUI CTS-5500/CTS-6600 is a portable diagnostic ultrasound system capable of the following operating modes: 2D (B mode), M and B/M. The system is designed for use in linear and convex scanning modes and supports linear and convex transducers. The system has cine review, image zoom, measurements and calculations, printing and recording capabilities. The system consists of probes, main unit, control panel and monitor.
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