Screenpoint Medical B.V. 1.5.0 2D Transpara

The ScreenPoint Transpara system is intended for use as a concurrent reading aid for physicians interpreting screening mammograms from compatible FFDMsystems, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes marks placed on suspicious soft tissue lesions and suspicious calcifications, region based scores, displayed upon the physicians query, 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.