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.