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510(k) Data Aggregation

    K Number
    K072665
    Device Name
    SUNIRAY 5.2
    Date Cleared
    2007-10-03

    (12 days)

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

    **ORANGEDENTAL GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Uses for SuniRay in the dental industry are as follows: - Organize and archive radiographs and patient related files - Facilitate sharing and transmission of information between doctors, other applications and other computers - Place markers and annotations on radiographs for diagnostic purposes - Allows users to dimension radiographs based on dimensions of X-ray sensors or reference objects. - Provides image-processing tools such as sharpening, colorizing, resizing, etc. (none of which physically alter images). - Permits sending of data by email. The target group for using SuniRay for diagnostic purposes will be the doctor/dentist population. This software is primarily used to store a patient's imaging data (i.e. radiographs) in a form compatible with today's networked online medical practice management software may also be used to transmit radiographs to specialists who will be treating the patient or the insurance company for approval of procedure and etc.
    Device Description
    SuniRay is a software package designed to work with Standard PC compatible computers capable of running a Microsoft Windows operating system. The software is designed to be a fully functional digital radiograph scanning, archiving, electronic transmission and diagnostic review system. SuniRay permits the acquisition of images directly from commercially available scanners, digital cameras, intra-oral X-ray sensors, panoramic X-ray machines, etc. Once an image has been converted into digital format, SuniRay permits the user to easily organize and archive digital radiographs, images, and other patient related files. SuniRay provides tools that permit the user to enhance images and place markers as well as annotations on radiographs to aid in the diagnostic process. The image enhancements provided by this software package utilize industry standard algorithms that do not result in the alteration of an image's or a radiograph's content. Once imported into SuniRay, the original image content is never chancements are stored separately from the original image. Unlike a direct digital system, SuniRay does not control the X-ray taking system and does not generate radiographs directly from the physical world (SuniRay processes images and radiographs produced from other devices and physical media). Sun!Ray only permits enhancing radiographs for diagnostic purposes and does not allow the introduction of false data or the modification of the original images and radiographs in any way. To facilitate enhanced correlation of information with images, SuniRay permits direct association of customized information with an image. Using those associations the user is able to relate doctor information, patient's information, applied procedures, etc. with an image.
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