Evaluation of a Three Dimensional Functional Metabolic Imaging and Risk Assessment System in Classifying Women for Likelihood of Breast Cancer

Exclusion Criteria

• •1. Contraindication to bilateral mammography or MRI.
• •2. Subjects who are unable to read, understand and execute the informed consent procedure.
• •3. Subjects who have had mammography, ultrasound or MRI examination performed on the day of the study prior to MIRA scan.
• •4. Subjects who have significant existing breast trauma.
• •5. Subjects who have undergone lumpectomy/mastectomy.
• •6. Subjects who have undergone breast reduction or breast augmentation.
• •7. Subjects who have undergone any other type of breast surgery.
• •8. Subjects who have large breast scar / Breast deformation.
• •9. Subjects who have undergone a breast needle biopsy within the 6-month period prior to their intended enrollment into the study.
• •10. Subjects who have a temperature \> 37.8C degrees on the day of the MIRA imaging.
• •11. Subjects who are pregnant or lactating.
• •12. Subjects who have had placement of an internal breast marker.
• •13. Subjects with known Raynaud's Disease.
• •14. Subjects that are claustrophobic or have physical limitations that do not allow them to sit in the system chair for the required imaging session.
• •15. Subjects with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices.
• •16. Inmates or mentally disabled individuals.
• •17. Subjects with a BI-RADS category 6 (e.g. for which mammogram was performed for the purpose of planning cancer therapy).
• •18. Subjects who participated in the Calibration Phase will not be able to participate in the Testing Phase.
• •19. Subjects currently participating in another investigational clinical study.
• •20. Subjects undergoing breast MR for pre-staging.
• •21. Subjects with known Mastitis