This registry has been designed to obtain real-life, post-market data on the use of the Imagio breast imaging system. This registry is sponsored by Seno Medical Instruments, Inc., the manufacturer of the device.

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:

1. Have been informed of the nature of the registry and provided written informed consent, prior to initiation of any registry activities,
2. Are females 18 years of age or older at the time of consent,
3. 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:

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

A total of up to 600 subjects will be enrolled in the registry in up to 12 sites in the EU and US, with a maximum of 50-100 subjects per site.

Subjects with lesions/masses presenting with BI-RADS 0-6 will be enrolled. Enrollment into the registry will allow for only 100 lesions/masses presenting with BI-RADS 1 and 2 breast imaging findings and evaluated with the Imagio breast imaging system and 50 lesions/masses presenting with BI-RADS 0 findings and evaluated with the Imagio breast imaging system. This limitation is applicable in order to ensure a cross section of BI-RADS categories enrolled in the registry.

Your medical history, information from your medical record (i.e., Imagio images, other standard imaging (screening/diagnostic ultrasounds, MRI, diagnostic ultrasound, Mammography, etc.), pathology results, and other information you give us during an interview or from questionnaires, demographic information like your age, ethnicity or race). In an effort to protect your privacy, the study staff will use code numbers instead of your name, to identify your health information. Initials and numbers will be used on any photocopies of your study records. If the results of this study are reported in medical journals or at meetings, you will not be identified. Every effort is made to ensure that your personal information is removed from these images.

September 2024

The following groups can access the IPD.

To assess accuracy of Imagio:

• Study staff
• Imaging Core Lab
• Seno
• Doctors, independent of your doctor's office

Institutions and other persons who are required to review research and monitor medical products/therapies and the conduct of research:

• FDA
• DHHS
• Other U.S. and foreign government authorities
• Institutional Review Boards
• Seno representatives