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The Epredia E1000 Dx Digital Pathology Solution is an automated digital slide creation, viewing, and management system. The Epredia E1000 Dx Digital Pathology Solution is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The Epredia E1000 Dx Digital Pathology Solution is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. The Epredia E1000 Dx Digital Pathology Solution consists of a Scanner (E1000 Dx Digital Pathology Scanner), which generates in MRXS image file format, E1000 Dx Scanner Software, Image Management System (E1000 Dx IMS), E1000 Dx Viewer Software, and Display (Barco MDPC-8127). The Epredia E1000 Dx Digital Pathology Solution is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using Epredia E1000 Dx Digital Pathology Solution.

The E1000 Dx Digital Pathology Solution is a high-capacity, automated whole slide imaging system for the creation, viewing, and management of digital images of surgical pathology slides. It allows whole slide digital images to be viewed on a display monitor that would otherwise be appropriate for manual visualization by conventional brightfield microscopy. The E1000 Dx Digital Pathology Solution consists of the following three components: Scanner component: - . E1000 Dx Digital Pathology Scanner with E1000 firmware version 2.0.3 - . E1000 Dx Scanner Software version 2.0.3 Viewer component: - E1000 Dx Image Management System (IMS) Server version 2.3.2 ● - . E1000 Dx Viewer Software version 2.7.2 Display component: - . Barco MDPC-8127 The E1000 Dx Digital Pathology Solution automatically creates digital whole slide images by scanning formalin-fixed, paraffin-embedded (FFPE) tissue slides, with a capacity to process up to 1,000 slides. The E1000 Dx Scanner Software (EDSS), which runs on the scanner workstation, controls the operation of the E1000 Dx Digital Pathology Scanner. The scanner workstation, provided with the E1000 Dx Digital Pathology Solution, includes a PC, monitor, kevboard, and mouse. The solution uses a proprietary MRXS format to store and transmit images between the E1000 Dx Digital Pathology Scanner and the E1000 Dx Image Management System (IMS). The E1000 Dx IMS is a software component intended for use with the Barco MDPC-8127 display monitor and runs on a separate, customer-provided pathologist viewing workstation PC. The E1000 Dx Viewer, an application managed through the E1000 Dx IMS, allows the obtained digital whole slide images to be annotated, stored, accessed, and examined on Barco MDPC-8127 video display monitor. This functionality aids pathologists in interpreting digital images as an alternative to conventional brightfield microscopy.