Thermal Imaging Systems

Thermal imaging systems, may be used to measure surface skin temperature. These systems include an infrared thermal camera and may have a temperature reference source. When used correctly, thermal imaging systems generally have been shown to accurately measure someone’s surface skin temperature without being physically close to the person being evaluated. Thermal imaging systems offer certain benefits in that other methods need a closer proximity or contact to measure temperature (for example, non-contact infrared thermometers or oral thermometers). Thermal imaging system may measure surface skin temperature faster than the typical forehead or oral (mouth) thermometer that requires a close distance or physical contact with the person being evaluated.. Scientific studies show that, when used correctly, thermal imaging systems generally measure surface skin temperature accurately. We offer a broad range of thermal imaging systems from individual systems (measuring one person at a time) with face recognition, systems without face recognition and crowd scanners measuring many people at a time.

Telethermographic systems may be marketed to the general public for general, non-medical purposes, such as use in construction and other industrial applications. Because they are not intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, when marketed for these non-medical applications, FDA device marketing authorization is not required, and all the other medical device requirements of the FD&C Act do not apply to manufacturers, importers, and distributors of these products.

FDA: Thermal Imaging Systems (Infrared Thermographic Systems / Thermal Imaging Cameras)

Enforcement Policy for Telethermographic Systems

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