Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System

Inclusion Criteria:

Women between the ages of 20 and 80 years of age, who are either healthy or who are
scheduled to undergo a tissue biopsy of surgical excision of a suspicious breast lesion
for histopathologic diagnosis.

Exclusion Criteria:

For the Healthy Volunteers Population,

- subjects with a history of minor breast procedures involving either breast;

- subjects with a history of major breast procedures involving either breast;

- subjects with a history of significant acute breast abnormalities involving either
breast; and

- subjects with a history of significant chronic breast abnormalities involving either
breast; and

For Referred For Biopsy Population,

- subjects with a history of minor breast procedures involving either breast that were
performed within 6 months prior to enrollment or which have not completed active
healing at the time of enrollment;

- subjects with a history of major breast procedures involving either breast;

- subjects with a history of significant acute breast abnormalities involving either
breast which have not completed active healing or resolution within 6 months prior to
enrollment; and

- subjects with a history of significant chronic breast abnormalities involving either
breast.