ClariSIGMAM is a software application intended for use with compatible full field digital mammography systems. The product calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates.
ClariSIGMAM uses this numerical value to provide breast density category in BI-RADS 5th edition (CE-cleared) to aid interpreting physicians in the assessment of breast tissue composition. ClariSIGMAM produces adjunctive information. It is not a diagnostic aid.