Emanuel Kanal 0

Request that FDA require MR manufacturers to provide 3D RF field plots

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We, the undersigned, respectfully request of the Food and Drug Administration to henceforth require of MR device manufacturers more detailed three dimensional spatial distribution maps of transmitted RF (i.e., B1) energies associated with each of their RF coils designed for radiofrequency energy transmission. Access to this information should be considered a vital and necessary piece of information contributing to safe utilization of the MR scanning hardware for those charged with its safe operation, and could potentiate safer MR scans on at least some of our patients compared to the Z-axis-only two dimensional RF field data provided today. While we recognize that the information provided today is targeted to help clarify potential exposure levels for workers in the region of the MR scanner during active imaging, we believe that this information should be considered basic and necessary for all MR operators for routine safe usage of this equipment, and should be widely available to all who operate any and all MR imaging equipment for diagnostic and/or therapeutic human imaging objectives.

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