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510(k) Data Aggregation

    K Number
    K113613
    Device Name
    DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM
    Manufacturer
    SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS
    Date Cleared
    2012-06-15

    (192 days)

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

    SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS

    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, trans-vaginal, trans-rectal and peripheral vascular applications. Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular, trans-vaginal and trans-rectal applications in B, M, PWD, CWD, Color Doppler and 3D imaging modes.
    Device Description
    The SIUI Apogee 1200 is a Digital Ultrasound Imaging System capable of the following operating modes: 2D (B mode), M, Doppler (PWD/CWD 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, 3D and endocavity (trans-vaginal and trans-rectal) 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
    K092907
    Device Name
    DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR
    Manufacturer
    SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS
    Date Cleared
    2010-03-05

    (164 days)

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

    SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS

    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 CTS-8800 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
    K081110
    Device Name
    SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM
    Manufacturer
    SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS
    Date Cleared
    2008-05-16

    (28 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organ, cardiac, peripheral vascular and muscular-skeletal applications.
    Device Description
    The SIUI CTS-900 is a digital diagnostic ultrasound system capable of the following operating modes: 2D (B mode) 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, image storage and review, printing and recording capabilities. The system consists of probes, main unit, control panel and monitor.
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    K Number
    K070982
    Device Name
    CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM
    Manufacturer
    SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS
    Date Cleared
    2007-05-02

    (26 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS

    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. Muscular-Skeletal Conventional and Superficial applications. Small organs include: thyroid, testes, breast. Other uses include: Uterus, Ovary, and Prostate.
    Device Description
    The SIUI CTS-7700 is a digital diagnostic ultrasound system capable of the following operating modes: 2D (B mode) 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, image storage and review, printing and recording capabilities. The system consists of probes, main unit, control panel and monitor.
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    K Number
    K061083
    Device Name
    CTS-7700
    Manufacturer
    SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS
    Date Cleared
    2006-06-06

    (49 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS

    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-7700 is a digital diagnostic ultrasound system capable of the following operating modes: 2D (B mode) 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, image storage and review, printing and recording capabilities. The system consists of probes, main unit, control panel and monitor.
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    K Number
    K013327
    Device Name
    CTS-415
    Manufacturer
    SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS
    Date Cleared
    2001-12-14

    (70 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic Ultrasound System Indications for Use Form Device Name: CTS-415 Clinical Application: Fetal, Abdominal, Pediatric, Small Organ (specify), Cardiac, Peripheral Vascular Mode of Operation: B, M, Combined (specify) Small organs includes: thyroid, parathyroid, parotid, submaxillary gland testes and breast Pediatric Comments: Pediatric Intended Uses include: Cardiology. Abdomen. Peripheral Vasa Scanhead Indications for Use Form Device Name: Convex Array C3I40 Clinical Application: Fetal, Abdominal, Pediatric, Cardiac Mode of Operation: B, M, Combined (specify) Pediatric Comments: Pediatric Intended Uses include: Cardiology, Abdomen Scanhead Indications for Use Form Device Name: Linear Array L7I50 Clinical Application: Pediatric, Small Organ (specify), Peripheral Vascular Mode of Operation: B, M, Combined (specify) Small organs includes: thyroid, parotid, submaxillary gland. testes and breast Pediatric Intended Uses include: Peripheral Vasa Pediatric Comments:
    Device Description
    Model CTS-415 is a linear/convex electronic scanning ultrasonotomograph with a built-in digital scan converter (DSC) and main CPU module. The unit allows heart, abdominal organic and fetal tomographic images to be observable on a video monitor. The main unit is portable and is separable from other equipment to be carried for its use at another place as well as being usable in combination with a 9inch video monitor and a special photographic unit.
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    K Number
    K012772
    Device Name
    CTS-485 ULTRASOUND IMAGING SYSTEM
    Manufacturer
    SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS
    Date Cleared
    2001-10-01

    (45 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ultrasonic pulsed echo imaging and measurement for fetal imaging and other abdominal as well as pediatric, small organ cardiac. Small organs includes: thyroid, parathyroid, parotid, submaxillary gland, testes and breast. Pediatric Intended Uses include: Cardiology, Abdomen, Peripheral Vasa.
    Device Description
    Model CTS-485 is a linear/convex electronic scanning ultrasonotomograph with a built-in digital scan converter (DSC) and main CPU module. The unit allows heart, abdominal organic and fetal tomographic images to be observable on a video monitor. The main unit is portable and is separable from other equipment to be carried for its use at another place as well as being usable in combination with a 9-inch video monitor and a special photographic unit.
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    K Number
    K984203
    Device Name
    SIUI APOGEE 800PLUS ULTRASOUND IMAGING SYSTEM
    Manufacturer
    SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS
    Date Cleared
    1999-11-01

    (342 days)

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

    SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ultrasonic pulsed echo imaging, measurement, color Doppler, and color velocity imaging for Fetal, Abdominal, Pediatric, Small Organ, and Peripheral Vascular.
    Device Description
    Apoqee 800 PLUS transmits ultrasound waves. receives the echoes, and generates images based on information contained in the echoes. The format in which the information is displayed depends on the imaging mode or modes that you select. The system is capable of real-time two-dimensional (2D) imaging, motion mode (M-mode) imaging, Doppler imaging, Power imaging, and color imaging. The system supports application and exam type presets, which means that the system is automatically optimized for the scanhead and application you have selected. Additionally, analysis protocols are made available so that you can store measurements in the patient's report. Physically the system consists of the monitor module, the control module, the main chassis, and transducers.
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    K Number
    K984161
    Device Name
    CTS-310(B)
    Manufacturer
    SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS
    Date Cleared
    1999-05-05

    (166 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ultrasonic pulsed echo imaging and measurement for fetal imaging and other abdominal as well as pediatric, small organ, neonatal cephalic, adult cephalic, and heart.
    Device Description
    Model CTS-310B is a linear/convex electronic scanning ultrasonotomograph with a built-in digital scan converter (DSC). The unit allows heart, abdominal organic and fetal tomographic images to be observable on a video monitor. The main unit is portable and is separable from other equipment to be carried for its use at another place as well as being usable in combination with a 9-inch video monitor and a special photographic unit.
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    K Number
    K963065
    Device Name
    CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS
    Manufacturer
    SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS
    Date Cleared
    1997-05-29

    (295 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging of the human body as follows: Fetal, Abdominal, Cardiac Adult (B mode, M mode)
    Device Description
    Model CTS-285 is a compact-type linear/convex electronic scanning ultrasound system with a built-in digital scan converter (DSC). The unit allows adult heart, abdominal organ and fetal tomographic images to be observable on a video monitor. The main unit is portable and is separable from other equipment to be carried for its use at another place as well as being usable in combination with a full keyboard, 9-inch video monitor and a special photographic unit.
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