To confirm that a definitive diagnosis can be made from the tissue sample collected using the Intact BLES when defined radiology and pathology criteria are met.

Inclusion Criteria:

• Patient must be a female at least 18 years of age at the time of Intact BLES biopsy
• Patient must have had an imaged abnormality found via mammography or sonography that warrants a biopsy for further diagnosis

Exclusion Criteria:

• Patients who have pre-pectoral breast implants
• Patients who have implantable devices such as pacemakers and defibrillators
• Patients who are pregnant or lactating
• Patients in whom the device is contraindicated
• Patients who are contraindicated for surgery due to factors such as anti-coagulant use which cannot be safely reversed or who exhibit fever or other clinical evidence of infection

Patients with an imaged breast abnormality found with mammography or sonography whose initial biopsy will be taken with the Intact BLES.