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510(k) Data Aggregation

    K Number
    K113421
    Device Name
    MINICAT
    Manufacturer
    XORAN TECHNOLOGIES, INC.
    Date Cleared
    2012-07-11

    (236 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    XORAN TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MiniCAT is an X-ray imaging device that constructs a three dimensional model of the head and neck from images taken during a rotational X-ray sequence. The MiniCAT is optimized for the imaging of the maxillofacial complex, temporal bone, sinuses, and for neuro-angiography.
    Device Description
    The MiniCAT is a dedicated X-ray imaging device that acquires a 360-degree rotation x-ray sequence of images. The MiniCAT consists of both software and hardware components. The software is used for image acquisition, processing, and viewing and consists of the following main functional units patient database, study (scan) acquisition, study reconstruction, study view, report generation, and file saving. The software also controls the hardware components of the device. The major hardware components include the X-ray source, scanning arm (motor), and detector.
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    K Number
    K073306
    Device Name
    XORANCONNECT
    Manufacturer
    XORAN TECHNOLOGIES, INC.
    Date Cleared
    2008-01-07

    (45 days)

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

    XORAN TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    XoranConnect is a medical imaging software system intended to display, edit, review, store, print and distribute images acquired from imaging devices such as Computed Tomography (CT), Magnetic Resonance (MR), Computed Radiography (CR), Ultrasound (US), Nuclear Medicine (NM), and other devices.
    Device Description
    XoranConnect™ is a web-based service designed to complement point-of-care medical imaging systems by providing point-of-expertise viewing and interpretation tools. XoranConnect™ runs on standard offthe-shelf PC and networking hardware, all of which has been manufactured by third party reputable manufacturers. The system performs these major functions. - Off-site data storage allows user studies to be stored off-site. . - Study viewer allows studies to be visualized and manipulated in 3D, multiplanar and other forms. . To accommodate the major functions, the overall system architecture includes the following distinct components: - XoranVault™ storage system (storage servers, dispatcher) . - XoranConnect™ viewing system (study server, web server, web client) . The storage (backup) system consists of one or more servers designed to store and serve stored imaging content on a RAID5 storage device. Imaging modality negotiates the connection and transfers study to the storage server. Once stored, imaging data is ready to be served to the requesting clients. When a user logs into the system by visiting a XoranConnect web page, study server begins to serve the data, which in turn is displayed in the user's web browser window. Any storage server may simultaneously serve multiple requests for images. It is the user's responsibility to ensure that the appropriate PC hardware and display device are used to run the XoranConnect™ software application. XoranConnect™ requires at all times an active Internet connection to operate. It is the user's responsibility to ensure that the connection that is being used provides the speed, stability and reliability required to utilize XoranConnect™ for any given purpose or application.
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    K Number
    K061834
    Device Name
    XCAT; XCAT FOR NEURO
    Manufacturer
    XORAN TECHNOLOGIES, INC.
    Date Cleared
    2006-08-07

    (39 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    XORAN TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XCAT is intended to be used for x-ray computed tomography imaging of anatomy that safely fits into the imaging gantry (such as the head, neck, wrist, ankle, hand, and foot).
    Device Description
    The xCAT™ is a dedicated X-ray imaging device that acquires a 360° rotational X-ray sequence, reconstructs a three-dimensional matrix of the examined volume and produces two dimensional views of this volume. The xCAT™ can measure distances and thickness on two dimensional images. Images produced by the xCAT can be exported via Ethernet or onto optical media or a memory stick. The building blocks of the xCAT are a motorized scanning arm carrying an Xray source and image detector, and a computer running the xCAT software. The scanning arm facilitates the acquisition of a full X-ray sequence by the software. The software receives the two dimensional images acquired by the detector transforms them into three dimensional images and displays them on the computer monitor for viewing.
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    K Number
    K032243
    Device Name
    MINICAT DENTOCAT
    Manufacturer
    XORAN TECHNOLOGIES, INC.
    Date Cleared
    2003-10-02

    (72 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    XORAN TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MiniCAT™ is an X-ray imaging device that constructs a three dimensional model of the head and neck are from images taken during a rotational X-ray sequence. The MiniCAT™ is optimized for the imaging of the maxillofacial complex, temporal bone, sinuses, and for neuro-angiography.
    Device Description
    The MiniCAT™ is a dedicated X-ray imaging device that acquires a 360° rotational Xray sequence, reconstructs a three-dimensional matrix of the examined volume and produces two dimensional views of this volume. The MiniCAT™ can measure distances and thickness on two dimensional images. Images produced by the MiniCAT™ can be printed or exported on magnetic and optical media. The building blocks of the MiniCAT™ are a motorized scanning arm carrying an X-ray source and image detector, and a computer running the MiniCAT™ software. The scanning arm facilitates the acquisition of a full X-ray sequence by the software. The software receives the two dimensional images acquired by the detector transforms them into three dimensional images and displays them on the computer monitor for viewing.
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