Parascript® AccuDetect® is a Computer-Aided Detection (CAD) software device intended to aid radiologists reading mammograms. It is a proprietary software application designed to process FFDM images. The digital mammography images are automatically analyzed to identify areas suspicious for possible soft tissue densities and/or calcifications. Results are displayed on a computer monitor for review by a radiologist. The radiologist is instructed to first review each case in the conventional manner and then re-examine the case utilizing the information supplied by the Parascript® AccuDetect system before making a final assessment for the case.AccuDetect® is not a diagnostic device, as the CAD marks are intended to be used to assist only in detection and not in interpretation. Therefore, AccuDetect® can assist a radiologist in detecting areas of concern that would have been missed without its use, but if used properly it cannot cause a radiologist to miss areas of concern that would have been detected without AccuDetect®.
A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/ disc burning) and/or image manipulation and quantification (e.g., non-interpretive graphical overlays).
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