TY pruss - i'm just too tired to read and doing it half-assed isn't my cup of tea. If you can summize it would be nice. I think we might go green by the end of the day or at worst be ahead of the game tomorrow. It would solidify the MM manipulation. All the best to the BOARD.
imho. I work in a cardiovascular lab. I have seen head spins with xray tubes that produce 3d images of the vascular system or any other parts of the body for that matter. I believe this to be substantially similar to what I3 is doing in a portable format. The Dominion is NOT an implantable device as most of the examples for class 3 devices and does not produce as much radiation as a full CT scan which seems to have become ubiquitous. I would think that it may well fit into class 3 devices but generally approved under the 510k filing under the "not substantially different technology" than the spin technology already on the market in a fixed format. I do not know what the class submission is for this device, does anyone know?
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