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Thermographic Imaging Cameras
 We get many questions on our ditigital camera imaging system. Peter Leando of Meditherm gives us insight into the thermography camera used by BRAS. Here is what Peter has to say. "All Meditherm cameras are wholly built as classified medical device's in the Meditherm factory in Portland, OR . This factory is FDA licensed as a medical device manufacturing facility. The Meditherm FDA Manufacturer registration number is: 3006111110 . The Meditherm products are medically classified as Class I Medical Devices (Medical Device Directive rule 12). In regard to interpretation of findings: Medical-grade statistical analysis requires regional areas that are comparative for clinically relevant results. Single "spot" temperatures manually applied (as with many industrial cameras) will not be clinically significant or accurate. The interpretation should not be based on visual color scale but on statistical analysis and pattern recognition (either computerized, visual or both).The medical doctors reading Meditherm images have the ability to use vascular enhancement, 3-D modeling, first derivative subtraction modeling and change over time algorithms that help provide objective findings to contribute to their conclusion and opinions. State medical board opinion is that the interpretation and reporting of thermal studies is the practice of medicine and does need to be within the scope of the reporting doctor. It is necessary to ensure that any persons interpreting thermal results are licensed to practice medicine. Meditherm products have always exceeded all necessary specifications for medical use." |