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510(k) Data Aggregation

    K Number
    K090623
    Device Name
    DIGITAL RADIOGRAPHY CXDI-40G COMPACT
    Manufacturer
    CANON U.S.A., INC.
    Date Cleared
    2009-03-24

    (15 days)

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

    CANON U.S.A., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DIGITAL RADIOGRAPHY CXD1-40G COMPACT 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. This device is not intended for mammography applications.
    Device Description
    DIGITAL RADIOGRAPHY CXDI-40G COMPACT, designed for easy installation in bucky unit, 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 DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations.
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    K Number
    K033624
    Device Name
    PACS SOFTWARE SOLUTION 2003
    Manufacturer
    CANON U.S.A., INC.
    Date Cleared
    2003-12-15

    (27 days)

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

    CANON U.S.A., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PACS Software Solution 2003 is intended to be used by radiologists and other medical professionals for purposes of diagnosis, or for clinical review, by viewing medical images on digital display devices or hard copy printouts. PSS03 provides an efficient interface to medical images and manages the archiving of medical images for short and long term storage. PSS03 is intended to be used with imaging equipment (e.g., Magnetic Resonance Imaging (MRI), Computerized Tomography (CT), Digital Radiography (DR), Ultrasound (US), etc.) and patient information systems (e.g., Hospital Information Systems (HIS), Radiology Information Systems (RIS)) approved for medical use. PACS Software Solution 2003 is used to acquire, process, display, evaluate, archive, print and distribute DICOM compliant images for clinical purposes. Images may be acquired from imaging modalities such as CR, CT, MR, X-Ray, and other devices.
    Device Description
    PACS Software Solution 2003 (PSS03)' is proprietary software used in conjunction with computer hardware to provide a Picture Archiving and Communication System. PSS03 has been designed to manage medical imaging data from various imaging devices (e.g. Magnetic Resonance Imaging, Computerized Tomography, Digital Radiography, Ultrasound, etc.). Management of medical imaging data from these devices, enabled by PSS03, includes display tools, the support of industry standard communication protocols (e.g. Transfer Control Protocol/Internet Protocol, Digital Communication in Medicine, Ethernet, etc.) and archiving of data using hierarchical protocols. The system provides redundant storage of the exam data. PSS03 accommodates individual user preferences by automatically displaying medical images in a presentation format unique to the user and to the type of exam selected. PSS03 is highly scalable, providing a small facility or a large enterprise of facilities the same functionality.
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    K Number
    K031633
    Device Name
    CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C
    Manufacturer
    CANON U.S.A., INC.
    Date Cleared
    2003-06-11

    (15 days)

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

    CANON U.S.A., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CANON DIGITAL RADIOGRAPHY CXDI-40C 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
    The Canon digital radiography CXDI-40C 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 DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations. The CXDI-40C uses CsI (Cesium Iodide) as the fluorescent screen deposited on the amorphous silicon array, while the predicate CXDI-40G uses GOS (Gadolium Oxy-Sulfide). The CXDI-40C delivers diagnostic images with approximately half the xray dosage required by CXDI-40G and CXDI-40C's DQE approximately doubles compared to CXDI-40G. The CXDI-40C's imaging size, number of pixels and pixel pitch are the same as those of CXDI-40G. CXDI-40C operates in conjunction with an upright stand, table, and universal stand. CXDI-40C's housing size and shape are almost as same as those of CXDI-40G. A Control PC is required to operate the CXDI-40C.
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    K Number
    K031629
    Device Name
    CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI
    Manufacturer
    CANON U.S.A., INC.
    Date Cleared
    2003-06-06

    (10 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    CANON U.S.A., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Canon Non-Mydriatic Retinal Camera CR-DGi is intended to be used for taking pictures of retina of human eye without a mydriatic.
    Device Description
    CR-DGi is an improved model of CR5-45NM.
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    K Number
    K023750
    Device Name
    CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G
    Manufacturer
    CANON U.S.A., INC.
    Date Cleared
    2002-11-22

    (14 days)

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

    CANON U.S.A., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CANON DIGITAL RADIOGRAPHY CXDI-40G 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
    The Canon digital radiography CXDI-40G 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 DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations.
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    K Number
    K023586
    Device Name
    DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS
    Manufacturer
    CANON U.S.A., INC.
    Date Cleared
    2002-11-05

    (11 days)

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

    CANON U.S.A., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DR-ER version of Canon's X-ray Digital Cameras 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
    The Canon X-ray digital camera model CXDI-11 DR-ER add. version 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 DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations. The Canon X-ray digital camcra model CXDI-22 DR-ER add. version 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 DICOM compatible digital network for printing. The device provides digital image capure for conventional film/screen radiographic examinations. The Canon X-ray digital camera model CXDI-31 DR-ER add. version 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 DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations.
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    K Number
    K003689
    Device Name
    CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31
    Manufacturer
    CANON U.S.A., INC.
    Date Cleared
    2002-01-02

    (398 days)

    Product Code
    IXK
    Regulation Number
    892.1630
    Why did this record match?
    Applicant Name (Manufacturer) :

    CANON U.S.A., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992606
    Device Name
    CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100
    Manufacturer
    CANON U.S.A., INC.
    Date Cleared
    2000-06-21

    (323 days)

    Product Code
    HLI
    Regulation Number
    886.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    CANON U.S.A., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Canon Laser Blood Flowmeter CLBF model 100 is intended for use in observing patient's fundus (retina) with the information of blood flow (velocity) in a retinal vessel. The information of blood flow is also obtained by CLBF model 100, and it is intended to help doctors' reading of retinal images.
    Device Description
    The Canon Laser Blood Flowmeter (CLBF) Model 100 allows for fundus observation with velocity measurement of retinal blood flow.
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    K Number
    K992547
    Device Name
    CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22
    Manufacturer
    CANON U.S.A., INC.
    Date Cleared
    1999-10-13

    (75 days)

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

    CANON U.S.A., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CANON X-RAY DIGITAL CAMERA CXDI-22 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
    The Canon X-ray digital camera model CXDI-22 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 DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations.
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    K Number
    K981556
    Device Name
    CANON X-RAY DIGITAL CAMERA CXDI-11
    Manufacturer
    CANON U.S.A., INC.
    Date Cleared
    1998-11-04

    (187 days)

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

    CANON U.S.A., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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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