1. FDA Presentation P010035 Computerized Thermal Imaging, Inc. CTI™ BCS 2100

2. Modular PMA Submission M990018 Module 1 – Preliminary Information Review John Monahan Module 2 – Software Review Joseph Jorgens III Module 3 - Manufacturing Review Xuan Vo Module 4 – Engineering Review Jim Seiler

3. P010035 Reviewers Lead Reviewer – John C. Monahan Clinical Reviewer – Wm. Sacks, Ph.D., M.D. Statistical Reviewer – Harry Bushar, Ph.D. Bioresearch Monitor – Kevin Hopson

4. Proposed Indication for Use The CTI BCS2100 is intended “for use as an adjunct to mammography to safely avoid biopsy of benign breast masses that would otherwise have undergone biopsy. A physician should not base a decision for patient care solely on the results of testing with this device...other findings and risk factors associated with a specific patient.

5. Proposed Indication for Use (cont.) “The CTI BCS2100 provides additional information to guide a breast biopsy recommendation. …use of the CTI BCS2100 should be limited to the evaluation of breast lesions that include ’mass’ as a lesion descriptor....

6. Proposed Indication for Use (cont.) “It is recommended that...all patients receiving a negative IR test result be similar to the recommendation for care of a mass that is assigned to mammographic category 3.That is, a short interval follow-up is recommended in order to establish the stability of the finding.”