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IMGGorBust

05/20/10 12:25 PM

#16330 RE: acm #16329

This is not true at all. The April 5 submission included 3D images from the DViS compared to 3D images from predicate devices that also generate 3D images (just not in real time).
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bart

05/20/10 12:27 PM

#16331 RE: acm #16329

No go ahead. Worry away. Let's see, what you're saying is that a company that is wishing to get approval for a 3-d imaging device sends in 2-d images for approval? That does sound like a stretch but I guess anything is possible in this strange FDA approval environment.
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borntwice

05/20/10 12:32 PM

#16333 RE: acm #16329

Why would they send 2D images for a 3D device?

This just doesn't make any sense..

How certain can we be that Mike sent this email?

That is bizarre...

So the FDA is going to approve a 2D device???

Somebody come to the rescue here...