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Re: borntwice post# 16260

Wednesday, 05/19/2010 11:56:25 PM

Wednesday, May 19, 2010 11:56:25 PM

Post# of 59551
Did you literally just copy and paste this post from 6 months ago? Are we really going to go through this nonsense again?

There are images from the DViS, both 2D and 3D, all over the place. There is a 3D image of a hand on Imaging3's website. There's a video at the top of this page from the RSNA showing 2D and 3D images. There are multiple videos on the Imaging3 website that show images from the DViS. If you make an appointment to meet with Imaging3's director of investor relations, they will bring you into their facility and show you the machine generating images in live time.

Dean has said he was reluctant to post any NEW images on the website because NEW images on the website would constitute new marketing materials for the device. He is 100% correct that it would constitute marketing materials. The FDA evaluates marketing materials when it reviews 510(k) applications. Putting out something new, without express approval from the FDA, would be utterly stupid. It won't upset them, but it will almost certainly delay the approval, because they would have to review the new materials. Why do it just to stop some whining?

Dean said that he would ask the FDA for the greenlight to post certain new images. If he gets that greenlight, all the better. It sounds like from GDSGDS that maybe Dean has that greenlight. If so great. If not, I'd rather just get the approval and see the new images later.