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See country-specific product labeling for regulatory status. Instrument Country Specific Labeling navify Digital Pathology (on-prem) navify® Digital Pathology (on-prem) INS_6887 10 617 284 001 10617284001 navify Digital Pathology 2.x - CDP navify Digital Pathology 2.x - CDP Electronic Services Not Available Not Available 09 453 628 001 9 453 628 001 09453628001 9453628001 09453628001 uPath enterprise software on prem - 2.x uPath enterprise software 07613336200230 Electronic Services Not Available Not Available 10 092 343 001 10092343001 navify Digital Pathology on prem - 2.x navify Digital Pathology on prem - 2.x 07613336227619 Electronic Services Not Available Not Available Roche Digital Pathology Dx is an automated digital slide creation, viewing and management system. Roche Digital Pathology Dx is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of scanned pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue. Roche Digital Pathology Dx is notintended for use with frozen section, cytology, or non-FFPE hematopathology specimens. Roche Digital Pathology Dx is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy.
Roche Digital Pathology Dx is composed of VENTANA DP 200 slide scanner, VENTANA DP 600 slide scanner, Roche uPath enterprise software, and ASUS PA248QV display. 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 Roche Digital Pathology Dx. en