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For In Vitro Diagnostic Use Concentriq® Dx is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret and manage these digital slide images of primary diagnosis. Concentriq® Dx is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and the validity of the interpretation of images using Concentriq Dx is intended for use with the Hamamatsu NanoZoomer S360MD Slide scanner and JVC JD-C240BN01A monitor.

CONCENTRIQ DX IS OPERATED AS FOLLOWS: - 1. The image acquisition is performed using the validated WSI scanner. A lab technician prepares, and scans slides and reviews the slide quality in accordance with the WSI scanner Instructional Manual and standard lab procedures. The Concentriq Dx workflow is initiated when the WSI from the local file system is ingested into Concentriq Dx. - 2. The reading pathologist selects a case from a worklist external to the subject device or from within the subject device, whereby the subject device fetches the associated images from the image storage. - 3. The reading pathologist uses the subject device to view and interpret the images: - Zoom and pan the image ● - Measure distances and areas in the image - Annotate the image ● - View multiple images side by side - 4. Prior to using a whole slide image for diagnosis, a data and image quality assessment is performed. - 5. The above steps are repeated as required. - 6. After viewing all images for a case, the pathologist will make a diagnosis. The diagnosis will be documented in another system, e.g., a Laboratory Information System (LIS). - 7. When finished using the system, the pathologist clicks "Sign Out" in the user menu. Quality Control: Prior to using a whole slide image for diagnosis, the pathologist should ensure that all scanned slide images have been imported for every case and the images are of acceptable quality for diagnostic purposes. The pathologist reviews scanned images from all the slides associated with a case before rendering a diagnosis.