Flir System AB – FDA Warning Letter

The FDA issued a Warning Letter to Central Coast Thermography Breast Health Imaging Centers on January 6, 2011, regarding the marketing of FLIR Telethermographic cameras. The FDA found that the company was promoting the FLIR Telethermographic camera for uses not cleared or approved by the FDA, violating the Federal Food, Drug, and Cosmetic Act.

The FLIR Telethermographic camera Series A, E, P, and S was cleared via 510(k) (K033967) on March 9, 2004, for use as an adjunct to other clinical diagnostic procedures in diagnosing, quantifying, and screening skin surface temperature changes, and to visualize and document temperature patterns. The cleared indication explicitly states it is not intended for use alone to diagnose or screen any disease.

However, the company's website (centralcoastthermography.com) and radio features made claims that the FLIR Telethermographic camera could be used as a stand-alone device to diagnose or screen various breast diseases and conditions, including detecting abnormalities years before mammograms, evaluating breasts with implants, detecting irregular vascular patterns, and creating risk assessments. Claims of 99% sensitivity, 90% specificity, and 90% accuracy for breast thermography were also made. The website and radio spots also suggested the device was a "safe alternative to mammograms" and could detect musculoskeletal disorders, inflammation, chronic pain, and injuries.