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510(k) Data Aggregation

    K Number
    K113442
    Device Name
    3DI
    Manufacturer
    SHINA SYSTEMS LTD.
    Date Cleared
    2012-02-16

    (87 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHINA SYSTEMS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3Di is intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own diagnosis, by providing tools of communication, clinics networking, WEB Serving, image viewing, image manipulation, 2D/3D image visualization, image processing, reporting and archiving. The 3Di indications for use are processing of Cardiac CT studies, including CT Calcium scoring, CT Cardiac angiography, coronaries analysis, cardiac functional assessment and of CT colonoscopy. The 3Di indications for use have been modified to include viewing of Mammography images.
    Device Description
    3Di is a PACS device which enables users to access medical images over a network and to utilize 3Di's image visualization tools to review the images. It provides the following functions: Web server, patient browser, PACS capabilities, multi-modality viewing, CT Cardiac and Colonoscopy clinical applications. The 3Di indications for use have been modified to include viewing of Mammography images.
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    K Number
    K112530
    Device Name
    3DI INCLUDING CSCORE
    Manufacturer
    SHINA SYSTEMS LTD.
    Date Cleared
    2011-09-30

    (30 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHINA SYSTEMS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3Di is a software package of PACS workstation for handling multimodality (CT, XA, MR, PET, SPECT & Ultrasound) images, which are using DICOM protocol. It includes volume rendering, Multi-planar reconstruction (MPR) and viewing of the inner and outer surfaces of organs as well as within their walls. 3Di is intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own diagnosis, by providing tools of communication, clinics networking, WEB Serving, image viewing, image manipulation, 2D/3D image visualization, image processing, reporting and archiving. This product is not intended for use with or for diagnostic interpretation of Mammography images. The 3Di indications for use are processing of Cardiac CT studies, including CT Calcium scoring, CT Cardiac angiography, coronaries analysis, cardiac functional assessment and of CT colonoscopy.
    Device Description
    3Di is a PACS device which enables users to access medical images over a network and to utilize 3Di's image visualization tools to review the images. It provides the following functions: Web server, patient browser, PACS capabilities, multi-modality viewing, CT Cardiac and Colonoscopy clinical applications. The 3Di has been modified to include the 3Di CScore -option, which is intended to process CT cardiac studies for CT Calcium scoring.
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    K Number
    K093703
    Device Name
    3DI
    Manufacturer
    SHINA SYSTEMS LTD.
    Date Cleared
    2010-01-19

    (49 days)

    Product Code
    LLZ, CFR
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHINA SYSTEMS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3Di is a software package of PACS workstation for handling multimodality (CT, XA, MR, PET, SPECT & Ultrasound) images, which are using DICOM protocol. It includes volume rendering, Multi-planar reconstruction (MPR) and viewing of the inner and outer surfaces of organs as well as within their walls. 3Di is intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own diagnosis, by providing tools of communication, clinics networking, WEB Serving, image viewing, image manipulation, 2D/3D image visualization, image processing, reporting and archiving. This product is not intended for use with or for diagnostic interpretation of Mammography images. The 3Di indications for use are processing of Cardiac CT angiography studies, including coronaries analysis, cardiac functional assessment and CT colonoscopy.
    Device Description
    3Di is a PACS device which enables users to access medical images over a network and to utilize 3Di's image visualization tools to review the images. It provides the following functions: Web server, patient browser, PACS capabilities, multi-modality viewing, CT Cardiac and Colonoscopy clinical applications.
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    K Number
    K070226
    Device Name
    CARDIOCT
    Manufacturer
    SHINA SYSTEMS LTD.
    Date Cleared
    2007-03-09

    (44 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHINA SYSTEMS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The system, which is comprised of diagnostic reading software, is intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary obstructive disease.
    Device Description
    The CardioCT (CCT) is a software application for viewing, evaluating and functionally analyzing cardiac CT images. The application is an interactive tool for radiologists and cardiologists and is used to visualize coronary anatomy, assess the state of the coronary arteries and execute functional analyses of the heart. This is accomplished by segmenting the heart tissues and coronary arteries and performing detailed evaluations of the coronary arteries and ventricular functions.
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