Software and Cameras for Medical Use
ICI P and S Series Cameras and ICI IR Flash version 1.0 Software can be used for medical infrared imaging.
ICI has U.S. FDA 510K Clearance on their ICI P and S Series cameras and IR Flash Software version 1.0. K073581
Indications for Use:
“The ICI P and S IR Cameras, which provides capture of skin surface temperature of any part of the body, and the IR Flash Software version 1.0, which provides visualization and reporting functionalities, are intended for use as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of relative skin surface temperature.
Environment of use: hospitals, sub-acute healthcare settings, public areas, i.e. airports.”
These systems are intended to be used adjunctively and not as a sole or standalone device.