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For In Vitro Diagnostic Use Viewer+ 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 digital images of pathology slides for primary diagnosis. Viewer+ 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, where necessary, use conventional light microscopy review when making a diagnostic decision. Viewer+ is intended for use with Hamamatsu NanoZoomer S360MD Slide scanner and BARCO MDPC-8127 display.

Viewer+, version 1.0.1, is a web-based software device that facilitates the viewing and navigating of digitized pathology images of slides prepared from FFPE-tissue specimens acquired from Hamamatsu NanoZoomer S360MD Slide scanner and viewed on BARCO MDPC-8127 display. Viewer+ renders these digitized pathology images for review, management, and navigation for pathology primary diagnosis. Viewer+ is operated as follows: - 1. Image acquisition is performed using the NanoZoomer S360MD Slide scanner according to its Instructions for Use. The operator performs quality control of the digital slides per the instructions of the NanoZoomer and lab specifications to determine if re-scans are necessary. - 2. Once image acquisition is complete and the image becomes available in the scanner's database file system, a separate medical image communications software (not part of the device) automatically uploads the image and its corresponding metadata to persistent cloud storage. Image and data integrity checks are performed during the upload to ensure data accuracy. - 3. The subject device enables the reading pathologist to open a patient case, view the images, and perform actions such as zooming, panning, measuring distances and areas, and annotating images as needed. After reviewing all images for a case, the pathologist will render a diagnosis.