Search Results
Found 1 results
510(k) Data Aggregation
K Number
K222757Device Name
Clarus Viewer
Manufacturer
Date Cleared
2023-02-24
(165 days)
Product Code
Regulation Number
892.2050Why 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.
Ask a Question
Ask a specific question about this device
Page 1 of 1