Artificial intelligence in mammography

Regulatory information

Transpara 1.6.0 is a CE-marked class IIa medical device under the EU Medical Devices Directive (MDD) for both full field digital mammography and digital breast tomosynthesis.

HealthMammo Software 2.2 is a CE-marked class IIa medical device under the EU MDD.

ProFound AI for Digital Breast Tomosynthesis and ProFound AI for 2D Mammography are CE-marked class IIa medical devices under the EU MDD. The PowerLook Server is CE marked as class I under the EU MDD.