The ThermPix® Thermovisual Camera is intended to view, measure, and record heat patterns andvariations. It is intended for use as adjunctive diagnostic imaging for thermally significant indicationsstemming from heat emitted from the human body. The significance of these thermal patterns andvariations is determined by professional investigation. This device is intended for use by qualifiedtechnical personnel. Clinical judgement and experience are required to review and interpret theinformation transmitted. The ThermPix® Thermovisual Camera is only for use in addition to other diagnostic medical devices.It does not provide any absolute measurement of temperature and should not be used for solescreening or diagnosis for any disease or condition.The system is not intended to be used as a thermometry device.
A system using infrared photography or other infrared detection techniques to produce images or graphical representations of the distribution of body surface temperature for the purpose of diagnosing and assessing various conditions and disease states. Also referred to as a thermography scanner. This system typically consists of a camera display unit that includes a scanning-condensing optical system, infrared detector, an operator's console, photographic cameras, black-body phantom, electronic or computerized controls, software and an image display and analysis units.
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