Overview
To evaluate the safety and efficacy of the proposed investigational device and assess its clinical utility in breast cancer screening and diagnosis to support continuing technology development of the investigational technology.
Eligibility
Inclusion Criteria:
- Subject is female of any race and ethnicity
- Subject is at least 35 years old
- Subject is indicated for a screening or diagnostic mammogram or breast biopsy
Exclusion Criteria:
- Subject is pregnant or thinks she may be pregnant
- Subject is wheelchair bound and cannot stand independently
- Subject has breast implants, cardiac pacemakers or IV ports in the mammography field of view
- Subject previously participated in the study