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510(k) Data Aggregation

    K Number
    K110801
    Device Name
    WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM
    Date Cleared
    2011-08-02

    (132 days)

    Product Code
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIRECT DIGITAL IMAGING TECHNOLOGY (BEIJING) INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The WV3000T Digital X-ray Direct Imaging Flat Panel Detector System provides a digital image capture capability for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The device has application wherever conventional screen-film systems are currently used.
    Device Description
    The WV300T Digital X-ray Direct Imaging Flat Panel Detector System is used to directly capture and convert conventional projection X-ray images to digital images. A image preview function can be displayed on a review monitor for viewing. The diagnostic image can be transmitted through LAN for diagnostic viewing and printing. The device provides digital image capture for conventional radiographic examinations, excluding fluoroscopic, angiographic and mammography applications. The system differs from traditional X-ray systems in that instead of exposing a film for subsequent wet chemical processing to create a hardcopy image, a device called a detector array is used to capture the image in electronic form. The digital data are then used to produce hardcopy and softcopy images. The WV3000T Digital X-ray Direct Imaging Flat Panel Detector System is composed of the following: A detector array is used to capture the diagnostic image, and transfer the image to system controller in digital format. An multi-box is used to control detector array, harmonize the working between the array controller and high-voltage generator for exposal synchronization. A system controller is used to enter patient demographic information, initiate the exposure process, review captured images, and accept or reject captured images. The system controller is also used to send images to a hardcopy printer, workstation, or archive, and manage images temporarily stored in its database. Here, the system controller is the software device and which should install in the PC hardware system purchased by themselves of customer. The system controller also can make some disposal for the original image, such as gain, offset and defective pixel correction. By capturing, previewing, and storing and image, the system enables an operator to check the quality of an image at the time of exposure without having to develop a film.
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    K Number
    K090062
    Device Name
    WV1417A DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM
    Date Cleared
    2009-05-18

    (129 days)

    Product Code
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIRECT DIGITAL IMAGING TECHNOLOGY (BEIJING) INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The WV1417A Digital X-ray Direct Imaging Flat Panel Detector System provides a digital image capture capability for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The device has application wherever conventional screen-film systems are currently used.
    Device Description
    The WV1417A Digital X-ray Direct Imaging Flat Panel Detector System is used to directly capture and convert conventional projection X-ray images to digital images. A image preview function can be displayed on a review monitor for viewing. The diagnostic image can be transmitted through LAN for diagnostic viewing and printing. The device provides digital image capture for conventional radiographic examinations, excluding fluoroscopic, angiographic and mammography applications. The system differs from traditional X-ray systems in that instead of exposing a film for subsequent wet chemical processing to create a hardcopy image, a device called a detector array is used to capture the image in electronic form. The digital data are then used to produce hardcopy and softcopy images. The WV1417A Digital X-ray Direct Imaging Flat Panel Detector System (Fig.VI-1) is composed of the following: A detector array is used to capture the diagnostic image. An array controller is used to control detector array, harmonize the working between the array controller and high-voltage generator for exposal synchronization and image transmission. A system controller is used to enter patient demographic information, initiate the exposure process, review captured images, and accept or reject captured images. The system controller is also used to send images to a hardcopy printer, workstation, or archive, and manage images temporarily stored in its database. Here, the system controller is the software device and which should install in the PC hardware system purchased by themselves of customer. The system controller also can make some disposal for the original image, such as gain, offset and defective pixel correction. By capturing, previewing, and storing and image, the system enables an operator to check the quality of an image at the time of exposure without having to develop a film.
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