Diagnostic digital imaging system workstation application software

Intended purpose

: iCAD ProFound AI for full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) software is a computer-assisted detection and diagnosis (CAD) Artificial Intelligence (AI) software device intended to be used concurrently by physicians while reading FFDM and DBT exams from compatible FFDM and DBT systems. The system detects soft tissue densities (masses, architectural distortions and asymmetries) and calcifications in the FFDM images and DBT slices. The detections and Certainty of Finding and Case Scores assist interpreting physicians in identifying soft tissue densities and calcifications that may be confirmed or dismissed by the interpreting physician.