FDA Requirements

All devices sold for medical use in the U.S. must be FDA registered (510)k and all companies selling thermography for medical purposes must be listed in the FDA Establishment Listings and can sell only devices with (510)k registration. To access this information go to here. The Product Code is LHQ

Thermography, an infrared imaging system used for medical application, must be an FDA registered Type II medical device. The physical risk to the patient is obviously very low, as a thermography camera does not expose the patient to harmful energy like radiation, but instead captures the infrared energy emitting from the body. However, the FDA is highly concerned about how thermography is represented to the patient, and rightly so.

Therefore, it is important to be aware that thermography is adjunctive. It is not a standalone diagnostic device. In fact, thermography is not recognized by the FDA as diagnostic for any specific disease with the exception of RSD. Thermography is appropriate as a safe and reliable screening device to detect changes that, if left unattended, could possibly progress into a late stage disease that can then be detected by other types of imaging devices. The FDA needs to be assured that all materials that are circulated to the public contain the clarification that "Thermography is not a standalone device and does not replace any other diagnostic device". You will see that Med-Hot makes this statement on this site and on all of our marketing materials. All companies advertising thermography devices or services must meet these requirements or be at risk of FDA investigation.

The highest and best use of medical thermography is:

A screening device for the purpose of assisting the health practitioner to care for their patients by promoting health and prevention of disease by using the physiological warning signs made possible by thermography or infrared imaging.

Did you know…

The FDA does not "approve" medical devices; instead it "registers" them as being documented to FDA satisfaction as reasonably safe. It is inappropriate to advertise thermography as "FDA APPROVED".

Med-Hot Thermal Imaging devices (510)k Registration
#K063047

Med-Hot Thermal Imaging Establishment Registration #3006033213