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

Exclusion Criteria10

• 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.