If we do infact have revolutionary software, and with your logic, nothing would ever get pushed by 510k approval because there is nothing equivalent. Well you may be right, you may be wrong, but playing devil's advocate, this software could become the new equivalent, I don't think at this juncture in time the software is getting visited that intensely. I don't even know how much the FDA would be looking into the software, there is so much more to this machine that is more important, and more important to the final product. That's all I'm going to say about that, decent point, but I think if software was the real cause we would have heard from the FDA way before that 510k wasn't the correct way to go on this. If FDA felt that the software was not able to be investigated or have an equivalent product then I think that this is something that would have been considered way way back in the process.
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