Prospective Case Collection Study of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational Device

Eligibility Criteria

• * Subject is female of any race and ethnicity.
• * Subject is at least 35 years old
• * Subject has a suspicious finding or breast abnormality on a screening or diagnostic mammogram and is indicated for a diagnostic exam or a biopsy procedure.
• * Subject is able to read, understand, and sign the study-specific informed consent form (ICF) after the nature of the study has been fully explained to them
• * Subject is unable or unwilling to undergo informed consent or subject who requires a Legally Authorized Representative (LAR) for Informed Consent.
• * Subject has breast implants, cardiac pacemakers, nipple piercings, or IV ports in the mammography field of view in the breast of interest.
• * Subject has had an interventional procedure in the same breast as the suspicious finding within the last six (6) months
• * Subject is pregnant or presumed to be pregnant.
• * Subject is breastfeeding.
• * Subject is actively being treated for cancer of any type with chemotherapy
• * Subject is suspected to be at risk of complications from the iodinated contrast agent. These include contra-indications of standard iodinated contrast agents, such as the subject having renal insufficiency) and the subject being on dialysis.
• * Subject has had a prior reaction to iodinated contrast; thus, a known allergy to iodinated contrast.
• * Subject has had a prior reaction to gadolinium contrast agents; thus, a known allergy to gadolinium contrast.
• * Subject who, based on the physician's judgment, may be at increased risk for complications associated with renal function, anticoagulant therapy, or bleeding disorders.