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.

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 has breast implants, cardiac pacemakers, nipple piercings, or IV ports in the mammography field of view.
• Subject previously participated in the study.

To protect participant privacy and comply with the IRB. The IRB did not approved the secondary use of IPD at the time the protocol was approved.