Evaluation of Real Imaging's 3D Functional Metabolic Imaging and Risk Assessment (MIRA) System

Exclusion Criteria

• •1. Women who have had a Mammography and/or US and/or MRI examination performed on the day of the study prior to MIRA scan
• •2. Women who had undergone mastectomy and/or breast reconstruction
• •3. Women who have had a breast biopsy performed throughout the 6 weeks preceding the study
• •4. Women who have a fever on the day of the MIRA imaging
• •5. Women who are pregnant
• •6. Women who are breast-feeding
• •7. Women with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices in the chest area
• •8. Women who are unable to read, understand and execute written informed consent
• •9. Women who are currently undergoing chemotherapy and/or radiotherapy
• •PHASE 2:
• •ARM 1:
• •1. Subjects who have had a Mammography and/or US and/or MRI examination performed on the day of the study prior to MIRA scan
• •2. Subjects scheduled for a diagnostic mammography due to a suspicious lump
• •3. Subjects who had undergone mastectomy and/or breast reconstruction
• •4. Subjects who have undergone breast reduction or breast augmentation.
• •5. Subjects who have large breast scar / breast deformation.
• •6. Subjects who have significant existing breast trauma.
• •7. Subjects who have undergone lumpectomy
• •8. Subjects who have had a breast needle biopsy performed throughout the 6 weeks preceding the study
• •9. Subjects with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices in the chest area
• •10. Subjects with known Raynaud's Disease.
• •11. Subjects who have a fever on the day of the MIRA imaging
• •12. Subjects who are pregnant
• •13. Subjects who are breast-feeding
• •14. Subjects with known Mastitis
• •15. Subjects who are currently undergoing chemotherapy and/or radiotherapy
• •16. Subjects with contraindication to bilateral mammography or MRI.
• •17. Subjects who participated in the Calibration Phase will not be able to participate in the Testing Phase.
• •18. Subjects currently participating in another clinical study.
• •19. Subjects who are unable to read, understand and execute written informed consent
• •ARM 2:
• •1. Subjects who have had a Mammography examination performed on the day of the study prior to MIRA scan
• •2. Subjects scheduled for a diagnostic mammography due to a suspicious lump
• •3. Subjects who have had a breast biopsy performed throughout the 6 weeks preceding the study
• •4. Subjects who have a fever on the day of the MIRA imaging
• •5. Subjects who are pregnant
• •6. Subjects who are breast-feeding
• •7. Subjects with known Mastitis
• •8. Subjects with known Raynaud's Disease.
• •9. Subjects who are currently undergoing chemotherapy and/or radiotherapy
• •10. Subjects with contraindication to bilateral mammography
• •11. Subjects who participated in the Calibration Phase will not be able to participate in the Testing Phase.
• •12. Subjects currently participating in another clinical study.
• •13. Subjects who are unable to read, understand and execute written informed consent