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510(k) Data Aggregation

    K Number
    K052661
    Device Name
    QUIX DIGITAL RADIOGRAPHIC UPGRADE
    Date Cleared
    2006-06-07

    (253 days)

    Product Code
    Regulation Number
    892.1680
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    Matched: '892.1840'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Quix Digital Radiography Upgrade is based on a solid state imaging device and is intended for use in general radiographic examinations and applications wherever conventional film-screen systems may be used, excluding mammography, fluoroscopy, and angiography.
    Device Description
    The Quix Digital Radiography Upgrade enables a conventional film-screen X-ray system to perform digital radiography exams by replacing the film-screen and the film-screen bucky with a digital bucky and operator console. The digital bucky incorporates a selenium-based flat panel detector with 16" x 17" imaging area. Images are displayed in approximately 10 seconds after exposure over a wide range of dose settings. The operator console provides local image storage and communicates with other network devices using DICOM 3.0 protocols.
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    K Number
    K013999
    Device Name
    LODOX, MODEL BASELINE
    Date Cleared
    2002-08-06

    (245 days)

    Product Code
    Regulation Number
    892.1750
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Lodox whole-body x-ray scanner is mainly intended for use in trauma wards where multiple injuries can be medically diagnosed in a very short time. It can also be used for normal x-ray examinations as is currently practised with general-purpose single-shot x-ray machines. A full image area is 1800 mm by 680 mm, and can be reduced to any size down to 100 mm by 100 mm anywhere within the image area.
    Device Description
    Lodox is a whole-body x-ray scanner that produces x-ray images that can be used for diagnostic purposes. It is an optical-based digital x-ray imager. It works by converting incident x-ray energy to visible light by use of a fluorescent screen optically coupled to a number of CCD cameras, which produce a digital image. The captured diagnostic image is stored in a database and is displayed on a highresolution, medical-quality monitor, where the diagnosis can be performed. The diagnostic image can be transmitted through a DICOM 3.0 compatible digital network for printing. The imaging area can be set from 100 mm x 100 mm x 680 mm on a special purpose patient trolley.
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    K Number
    K992955
    Device Name
    XPLORER 1000
    Date Cleared
    2000-06-02

    (275 days)

    Product Code
    Regulation Number
    892.1680
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended for use in general human radiography imaging similar to the optically coupled CCD based device cleared under 510(k) number K974863. Not to be used for mammography.
    Device Description
    The Xplorer 1000 is an optical based digital x-ray imager. It works by converting incident x-ray energy to visible light by use of fluorescent screen. The visible light is deflected by a mirror to a high resolution CCD camera that produces a digital image. The device trigger mechanism ensures that image is captured when the x-ray beam is turned on. The device does not require any connection to the x-ray generator.
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    K Number
    K981556
    Device Name
    CANON X-RAY DIGITAL CAMERA CXDI-11
    Manufacturer
    Date Cleared
    1998-11-04

    (187 days)

    Product Code
    Regulation Number
    892.1680
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CANON X-RAY DIGITAL CAMERA CXDI-11 is indicated for use in generating radiographic Images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. CANON X-RAY DIGITAL CAMERA CXDI-11 provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
    Device Description
    CANON X-RAY DIGITAL CAMERA CXDI-11 is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations. CANON X-RAY DIGITAL CAMERA CXDI-11 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 is used to capture the image in electronic form. The digital data are then used to produce diagnostic hardcopy and reference-softcopy images.
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    K Number
    K973206
    Device Name
    STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY
    Date Cleared
    1997-12-04

    (100 days)

    Product Code
    Regulation Number
    892.1680
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Direct Radiography™ device 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 Sterling Diagnostic Imaging Direct RadiographyTM device is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a digital network for diagnostic viewing and printing. The device provides digital image capture for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The Direct RadiographyTM device 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 digital array is used to capture the image in electronic form. The digital data are then used to produce hardcopy and softcopy images.
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