CONFIDENCE Registry

This is a prospective, controlled, multi-center, observational international registry designed to evaluate the Imagio breast imaging system. The registry will be conducted at up to 12 international centers. Investigators will use Imagio US (IUS) and/or Imagio OA/US imaging per standard of care, anddata will be collected accordingly. Additional imaging and biopsy/surgery will be conducted per standard of care to reach a final diagnosis.

Inclusion criteria

- Subjects must meet all the following criteria to be included in the registry:

• Have been informed of the nature of the registry and provided written informed consent, prior to initiation of any registry activities,
• Are females 18 years of age or older at the time of consent,
• Have been referred for a breast US and are subject to treatment with the Imagio breast imaging system.

Exclusion criteria

- Aligned with the contraindications on the use of the device, subjects who meet any of the following criteria will be excluded from the registry:

• Are pregnant.
• Have open sores including insect bites, rash, poison ivy, and chafing on the skin of the ipsilateral breast.
• Are experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as sulfa, ampicillin, tetracycline.
• Are currently undergoing phototherapy.
• Have a history of any photosensitive disease (e.g., porphyria, lupus erythematosus).
• Are undergoing treatment for a photosensitive disease and is experiencing photosensitivity.
• Have previously participated in this registry,
• Are currently enrolled in another investigational study or registry that would directly interfere with the current registry.