Device Dossier
Diagnostic digital imaging system workstation application software
Device Dossier for Diagnostic digital imaging system workstation application software (Diagnostic digital imaging system workstation application…
Intended purpose
PowerLook Density Assessment 3.4 is a software application intended for use with DBT 2D images from tomosynthesis exams. PowerLook Density Assessment 3.4 provides a BI-RADS 5th Edition breast density category to aid health care professionals in the assessment of breast tissue composition. PowerLook Density Assessment 3.4 produces adjunctive information. It is not a diagnostic aid.