Clinical Utility Study of a Low-Cost Hand-Held Breast Scanner

The FDA approved class II device in this clinical trial is a low-cost hand-held breast
scanner (intelligent Breast Exam, iBE). This device is to be used a pre-screening tool for
mammograms or ultrasounds. Determination of the accuracy of iBE for the detection of
clinically relevant breast lesions will be performed by means of a prospective study.

The iBE evaluation will be performed by a trained licensed practical nurse or ultrasound
technologist who is blinded to the outcome of the radiology studies at the time the iBE is
performed. The iBE training will be done by the leading iBE user in the United States. The
iBE evaluation will be done prior to the patient's original scheduled imaging visit. After
the completion of the imaging visit the radiologist will evaluate the mammogram and/or
ultrasound images along with the iBE report.

Inclusion Criteria:

- 18 years of age and older

- Women and men with symptomatic breast lump (either by palpation or imaging) OR

- Asymptomatic women presenting to the imaging center for a screening mammogram

- Signed Informed Consent

Exclusion Criteria:

- Patients under 18 years of age

- Patients who previously participated in this study and are returning to the Women's
Imaging Center for follow-up diagnostic tests