Low Dose Tomosynthesis Compared to Traditional Tomosynthesis

Low Dose Tomosynthesis Compared to Traditional Tomosynthesis

This study aims to evaluate image quality of a low-dose tomosynthesis system versus a comparator. Subjects will undergo a four-view tomosynthesis examination with the comparator and with the study device, and images will be assessed by several radiologists by comparing details in the images from the two systems.

Tomosynthesis is a relatively new technology to acquire mammographic images where images are acquired over several projection angles, giving 3d information that can help radiologists assess images.

The aim of the study is to see whether a new low-dose tomosynthesis system has comparable image quality at a lower x-ray radiation dose to a comparator.

Inclusion Criteria:

• Woman over 40 years of age
• Has a tomosynthesis examination with comparator
• Has a mammographic finding

Exclusion Criteria:

• Pregnant, breastfeeding or believes she may be pregnant
• Unable or unwilling to give informed consent