Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Breast Cancer Screening

Exclusion Criteria

• •1. Breast implants
• •2. Signs or symptoms of breast disease including changes in the size or shape of breast tissue, palpable lump, bloody or spontaneous clear nipple discharge, and/or eczema of the nipple
• •3. Weeping rash, open wounds, or unhealed sores on the breast
• •4. Bilateral mastectomy or unilateral mastectomy
• •5. Unable to lay prone on the scan table for up to 16 minutes
• •6. Unable to have breast positioned into the MUST device
• •7. Any breast surgeries in the past 12 months
• •8. History of cancer diagnosis and/or treatment in the past 5 years.
• •9. Unable or unwilling to undergo MRI if indicated