FDA Presentation P010035 Computerized Thermal Imaging, Inc.

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FDA Presentation P010035Computerized Thermal
Imaging, Inc.

• CTI BCS 2100

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Modular PMA SubmissionM990018

• 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

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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

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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.

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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. ...

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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
• That is, a short interval follow-up is
• recommended in order to establish the
• stability of the finding.