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510(k) Data Aggregation

    K Number
    K151371
    Device Name
    Corporate Dental Imaging (CDI) Application
    Date Cleared
    2015-08-19

    (90 days)

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

    U.S. ARMY DENTAL COMMAND (DENCOM)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Corporate Dental Imaging (CDI) Application™ is a software device for general dental diagnostic imaging. It controls capture, display, transfer, enhancement, and storage of X-ray dental images from digital imaging systems.
    Device Description
    The Corporate Dental Imaging (CDI) Application™ is a software application used for storing and displaying medical dental images. The application conforms to the DICOM 3.x standard to allow interoperability with other DICOM compliant systems. The implementation of CDI interface has been tested to assure compliance with the DICOM Conformance Statement. CDI is comprised of one (1) desktop client for Modality Image Capture, one (1) web-based client for Image Viewing and Diagnostics with Microsoft SQL Server back-end database(s) for storing DICOM images. CDI will capture images directly from intra-oral and extra-oral acquisition modalities, full color images from intra-oral cameras, digital cameras and other video sources. CDI is loaded onto the Acquisition PCs in the clinic where either the images will be acquired or where the images will need to be viewed. CDI will use the hardware vendor's own drivers to seamlessly initialize the acquisition modality from within the CDI UI. CDI will be designed to create a standard DICOM object that conforms to industry standards. CDI will also provide easy-to-use image processing tools that aid providers in analyzing images and making diagnoses. CDI will allow users to enhance the contrast and brightness of an image, reverse image values to show dental caries, and magnify specific areas of concern.
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