Clinical Evaluation of Opto-Acoustic Image Quality With the Gen 2 Imagio System

Exclusion Criteria

• •1. Is pregnant or lactating.
• •2. Has a condition or breast impediment (i.e. insect bites, poison ivy, rash, open wounds, chafing of the skin, scar, tattoos, moles, hematoma, nipple rings, etc.) which could interfere with the intended field of view.
• •3. Is experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as some sulfur containing drugs, ampicillin, tetracycline.
• •4. Is currently undergoing phototherapy.
• •5. Has a history of any photosensitive disease (e.g., porphyria, lupus erythematosus) or undergoing treatment for a photosensitive disease and is experiencing photosensitivity.
• •6. Has had an adverse reaction in the past to medical laser procedures, such as laser hair removal or laser tattoo removal.
• •7. Has had prior benign excisional breast biopsy on breast of interest within the past 18 months.
• •8. Currently has mastitis.
• •9. Prisoners