Food and Drug Administration

Radiological Devices Panel

December 10, 2002

Briefing Information

Purpose of the Meeting - To discuss, make recommendations and vote on a premarket approval application (PMA P010035) for a device that produces a computerized thermal image of the breast of women recommended for biopsy.

Disclaimer
The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

COMPUTERIZED THERMAL IMAGING, INC. (HTM) (PDF) (Word)