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For In Vitro Diagnostic Use Only CaloPix is a software only device for viewing and management of digital images of scanned surgical pathology slides prepared from Formalin-Fixed Paraffin Embedded (FFPE) tissue. CaloPix is intended for in vitro diagnostic use as an aid to the pathologist to review, interpret and manage these digital slide images for the purpose of primary diagnosis. CaloPix 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 CaloPix. CaloPix is intended to be used with the interoperable components specified in the below Table: | Scanner Hardware | Scanner Output File Format | Interoperable Displays | |---|---|---| | Leica Aperio GT 450 DX scanner | SVS | Dell U3223QE | | Hamamatsu NanoZoomer S360MD Slide scanner | NDPI | JVC Kenwood JD-C240BN01A |

CaloPix, version 6.1.0 IVDUS, is a web-based software-only device that is intended to aid pathology professionals in viewing, interpreting and managing digital Whole Slide Images (WSI) of glass slides obtained from the Hamamatsu NanoZoomer S360MD slide scanner (NDPI file format) and viewed on the JVC Kenwood JD-C240BN01A display, as well as those obtained from the Leica Aperio GT 450 DX scanner (SVS file format) and viewed on the Dell U3223QE display. CaloPix does not include any automated Image Analysis Applications that would constitute computer aided detection or diagnosis. CaloPix is for viewing digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. As a whole, CaloPix is a pathology Image Management System (IMS) which brings case-centric digital pathology image management, collaboration, and image processing. CaloPix consists of: - Integration with Laboratory Information Systems (LIS): Allows to obtain automatically from the LIS patient data associated with the cases, scanned whole slide images and other related medical images to be analyzed. The data stored in the database is automatically updated according to the interface protocol with the LIS. - DataBase: After ingestion, scanned WSI can be organized in the CaloPix database consisting of folders (cases) containing patient identification data and examination results from a LIS. Ingestion of the slides is performed through an integrated module that allows their automatic indexation based on patient data retrieved from the LIS. After their ingestion, image files are stored in a CaloPix-specific file storage environment, that can be on premises or in the cloud. - The CaloPix viewer component to process scanned whole slide images, that includes functions for panning, zooming, screen capture, annotations, distance and surface measurement, and image registration. This viewer relies on image servers (IMGSRV) which extract image tiles from the whole slide image file and send these tiles to the CaloPix viewer for smooth and fast viewing.