I don't think you guys quite understand the whole process? Most devices have one specific application for it's use, with equivalent devices already approved. This device has many applications, with no SE predicate device out there. When applying for approval, the quickest and simplest method would be to narrow down the uses you are applying for. For example..if you claim it will detect breast cancer, you must show it will do just that and do it without further complications. This is the FDA requesting further information regarding another application of the Dominion. I know it's not that simple, but, do you see what I mean?
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