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Re: prussian4profit post# 10361

Tuesday, 02/09/2010 1:23:10 PM

Tuesday, February 09, 2010 1:23:10 PM

Post# of 59549
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?

Going long