Concentriq® AP-Dx is a software only device intended for viewing and management of digital imagesof scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It isan aid to the pathologist to review, interpret and manage these digital slide images for the purpose ofprimary diagnosis. Concentriq AP-Dx is not intended for use with frozen sections, cytology, or non-FFPEhematopathology specimens.
An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).
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