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ltt05

08/25/10 5:01 PM

#24390 RE: IMGGorBust #24389

i believe Dean said the reviews said the images were of at least equal quality, and possibly better. he did not say the were definitively better, but all the FDA needs to know is that they are of equal quality.
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IMGGorBust

08/25/10 5:15 PM

#24391 RE: IMGGorBust #24389

To be specific, go to the conference call and listen at:

1:00:36 (they reviewed all the images from our product and the predicate devices and without question had no problem determining that our product was SE if not superior. I got exactly what I wanted out of it... Radiologists are very interested in buying stock after they've seen our product)

21:28 (2 radiologists reviewing our images and those of the predicate devices and determining that our images were of equal if not greater quality)

3:17 (affirmative of our product being SE, as good as, if not better)