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Re: IMGGorBust post# 8148

Thursday, 01/07/2010 10:59:09 AM

Thursday, January 07, 2010 10:59:09 AM

Post# of 59549
IMMG will gain approval from the 32bit images with the understanding that further improvements to the software is inevitable. The FDA only wanted improvement on the resolution of the images previously submitted, and since that submission the only thing the FDA came back with was a request for a "Labeling" clarification. If the FDA had issues with the current images submitted from the 32bit platform, they would have responded by now. Labeling is one of the last things to clarify before approval is granted.
To clarify: The labeling issue we are correcting most likely is for safety reasons, just like GE putting a label on a microwave warning people not to put metal in the device or serious injury may occur. It's a label for the dumb asses.