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510(k) Data Aggregation

    K Number
    K222757
    Device Name
    Clarus Viewer
    Date Cleared
    2023-02-24

    (165 days)

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

    Clarus Viewer Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Clarus Viewer® Version 1.0 is a software solution intended to be used for viewing, manipulation, storage, 3D-visualization, and comparison of medical images from multiple imaging modalities and/or multiple timepoints. The application supports images and anatomical datasets, limited to CT and MR. Clarus Viewer® supports the interpretation of examinations and follow-up documentation of findings within healthcare institutions, for example, in Radiology and other Medical Imaging environments. It is intended to provide image and related information that is interpreted by a trained professional but does not directly generate any diagnosis or potential findings. Note: The medical professional retains the ultimate responsibility for making the perfinent diagnosis based on their standard practices. Clarus Viewer is a complement to these standard procedures. Clarus Viewer® is not intended for the displaying of digital mammography images for diagnosis.
    Device Description
    Clarus Viewer® is a stand-alone software package that imports medical data in the Digital Imaging and Communications and Medicine (DICOM) standard, stored on local or remote PACS sources. Clarus Viewer® is intended to allow users to visualize and manipulate 2D and 3D images and models of CT and MRI datasets and visualize and manipulate 3D volumetric models. Clarus Viewer® can present the 2D and 3D images in either a desktop mode or in Virtual Reality. Within Clarus Viewer®, users can strip away layers of bone and tissue, revealing the relevant images for evaluation. Users can view and evaluate the 3D model from any angle. In the same way a doctor may hold and rotate a physical anatomical model in the real world, within Clarus Viewer® the image can be rotated and examined, or sliced away or apart to examine interior structures, tissues, and fluids. The Clarus Viewer® system is intended to be used as a supplemental viewer by trained medical professionals. It allows the user to view images, models, and related medical information that can then be interpreted by a trained professional. Clarus Viewer® does not directly generate any diagnosis. The medical professional retains the ultimate responsibility for making the diagnosis.
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