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Tuesday, May 24, 2011 3:05:18 PM
"These images were different anatomy, projections, and 3D reconstructive technique, therefore direct comparison was not possible"
That is a very good question Mugs. It may seem at first that the FDA had an issue with he device however, if you look at the context, the FDA was pointing out that Dean submitted images of a hand rather than a brain. Hence the different "anatomy". What about projections?.. This question was pertaining to the format of the media which was not what the FDA asked for. The information in that sentence that did not fit was 3d reconstructive technique. Why would the FDA question this?
In defense to the true Doctors who put their name on the line... they analyzed and concluded that even though Dean did not use the right "anatomy" it was still producing images as intended. Also, the projections although not the standard file extensions, it was still of high quality.
Mugs I ask you how did you analyze this line to get to your conclusion? I'd like to know your thought process.
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