Cone Beam Computed Tomography for Breast Imaging

Inclusion Criteria:

Group I:

- Females at least 35 years of age of any ethnicity

- Had a mammogram, read as BI-RADS® 1 or 2

- Will undergo study imaging no later than four weeks from date of mammogram.

- Is able to undergo informed consent.

Group II:

- Females at least 35 years of age of any ethnicity

- Require diagnostic imaging

- Will undergo study imaging no later than four weeks from date of diagnostic mammogram

- Is able to undergo informed consent

Exclusion Criteria:

Group I and Group II:

- Pregnancy

- Lactation

- Subjects with physical limitations that may prohibit resting prone on the exam table,
such as, but not limited to: frozen shoulder, recent heart surgery, pace maker.

- Subjects who are unable to tolerate study constraints.

- Subjects who have received radiation treatments to the thorax for malignant and
nonmalignant conditions, such as (but not limited to)

- Treatment for enlarged thymus gland as an infant

- Irradiation for benign breast conditions, including breast inflammation after
giving birth

- Treatment for Hodgkins disease

- Subjects who have participated in a prior breast clinical trial that gave additional
radiation dose, such as an additional mammogram.

- Subjects who have received large numbers of diagnostic x-ray examinations for
monitoring of disease such as (but not limited to)

- Tuberculosis

- Severe scoliosis