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# FDA Warns Unapproved Thermography Device Maker
- URL: https://www.fdaweb.com/fda-warns-unapproved-thermography-device-maker/
- Published: 2019-02-25T12:00:00.000Z
- Updated: 2026-09-15T01:07:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143454

FDA has issued a [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm631593.htm?ref=fdaweb.com) to Total Thermal Imaging (La Mesa, CA) for illegally marketing and distributing an unapproved thermography device as a sole screening device for breast cancer and other diseases. The agency also issued a [safety communication](https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm631885.htm?ref=fdaweb.com) to warn patients that thermography is not cleared as an alternative to mammography and should not replace mammography for breast cancer screening or diagnosis.

FDA says that thermography uses an infrared camera to produce images that show the patterns of heat and blood flow on or near the surface of the body. It has been cleared by the agency as an adjunctive tool for use alongside a primary diagnostic test like mammography, not as a standalone screening or diagnostic tool.

The Warning Letter also addresses recent inspection findings in which investigators observed several significant GMP deviations, such as failure to establish procedures for taking corrective or preventive actions to address any defective products and failure to establish procedures for receiving and evaluating complaints.