X-ray image interpretive software

Intended purpose

The ScreenPoint Transpara® system is intended for use as a concurrent reading aid for radiologists during interpretation of 2D and 3D mammograms of asymptomatic women to identify regions suspicious for breast cancer. Output of the device contains region-based scores indicating the likelihood that cancer is present in specific regions and an overall score indicating the likelihood that cancer is present on the mammogram. Patient management decisions should not be made solely on the basis of analysis by Transpara®.