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510(k) Data Aggregation

    K Number
    K100335
    Device Name
    ORS VISUAL
    Manufacturer
    OBJECT RESEARCH SYSTEMS, INC.
    Date Cleared
    2010-04-08

    (62 days)

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

    OBJECT RESEARCH SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORS Visual is a software-based Picture Archiving and Communication System (PACS) for the display and 3D visualization of medical image data. It provides for communication, storage, reformatting, rendering, and analysis of medical image data from various sources including CT and MRI. The ORS Visual software is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images are intended to be used to aid in diagnosis. It is the users' responsibility to ensure that the software is installed on appropriate hardware and that image quality is sufficient for the clinical application. Object Research Systems (ORS) recommends that users of the ORS Visual software consult the appropriate American College of Radiology (ACR) guidelines for the clinical setting and pathology being studied. Mammographic and compressed images are not supported for viewing. The software is not intended to replace the skill and judgment of a qualified medical professional. Users should be appropriately trained in the software's functions, capabilities and limitations. Users should be aware that certain views, and on the make use of interpolated data. This is data that is created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathological conditions or limited original data set resolution may be present. ORS Visual software must be installed on a suitable commercial computer platform. It is the users' responsibility to ensure that the hardware and display configurations are consistent with the clinical applications. Typical users of ORS Visual are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.
    Device Description
    The ORS Visual is a software-based Picture Archiving and Communication System (PACS) for the display and 3D visualization of medical image data. It provides for communication, storage, reformatting, rendering, and analysis of medical image data from various sources including CT and MRI.
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