it could be, but i would think that to request images and clarification of intended use around the same time is not what I would call homerun on approval. They had images, they had intended use, they didn't like ether one and had to change or provide new ones.
I just want to be clear here, these are just the negative possibilities that need to be considered. it could be all good, just not sure why all the other stuff like RSNA and no images were not so good. Also Dean saying it was basically a label, misled a lot of people and that makes me wonder "AM I ONE TOO?". Lets me just ask, would you of thought this was basically a label without Dean confirming it for ya? I sure wouldn't, and after i found out it was not labeling but part of the 510k process I was a little shaken by that. He should know this stuff, if he did he misled if he didn't what good is he in the FDA process?
Its really strange, I don't want to become emotionally vested in a stock, but a I also don't want to cheerleader it over a cliff either.
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