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Wednesday, July 18, 2007 3:12:14 PM
The response is simple the radiation dose for exposure is well within the legal limits so the FDA will have no problem with that aspect. Secondly, the radiation is comparable to a c-arm dose and in many instances far less, up to 52% less, which is part of our FDA application which they will be very happy with. Lastly, the CT dose range we use is extremely lower than standard CT, especially the new 64, 128 and 256 slice CT models, which the medical community is having a debate on whether the exposure is worth the diagnosis. Our CT uses cone beam CT which has been proven to be not only as effective, but does so at much lower exposure levels since it still remains in the fluoroscopy exposure range, not the significantly higher film or spot shot range. Our dose difference in the CT mode would be in the range of 100% to 1000% less depending upon what type of CT your are comparing it to.
Basically, we are providing advanced 3D imaging with the worst case being the same does as a c-arm exposure, best case 52% less.
Dean
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