i'm trying to comprehend what others are concerned about when it comes to the whole intended use thing...
so, maybe this is just a naive thought, but my logic tells me this...
the DViS is a fluoroscope first... with this in mind, it would seem to me that anywhere a physician will need to have realtime image guidance which is achieved through the assistance of a mobile unit (as provided by mobile fluoroscopy systems), it would be indicated.
what might be the thing which is being clarified with intended use is in regard to it's secondary feature, the cone beam CT technology. however, there are current portable cone beam CTs, which many, not all, are built/designed for an "application of specialty." so, maybe this is it, and i'd say okay, i'll give you that, but again, i really can't get my mind wrappped around that either...
it would seem that a "restriction" of the label would be, say, as compared to, something that is like the aquilion CT scanner... like for instance, okay the DViS is not intended to be used to perform CTAs, or computed tomography angiography, think coronary angios...
however, that just makes sense to me and i wouldn't think it would've been down that road to begin with...
or perhaps, there is discussion about whether the CT feature could be used for CT-guided biopsies... most typical application would be for lung biopsies. but, i don't know, 16 slice scanners were the industry norm til recently.
could it be used to assist radiation therapy planning, i would think yes, maybe... that sorta makes sense, and has been discussed by IMGG in the past...
back to "portable" CT scanners:
are portable CTs used for some surgeries, yes...again, it's one reason that they exist.
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unique to the DViS, as far as i'm aware, no one has weight-bearing CT applications... can the DViS do this, we are told yes. is weight bearing done in radiography, yes.
the interesting concept with this application is that...could it be used to help plan orthopaedic surgery on the knee... it would seem yes...
however, it is our understanding that this aspect of intended use will be applied for after initial clearance/approval...
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the real-magic, is that 3d imagery is becoming more commonplace. however, all is post processed, but nonetheless postprocessed 3d imaging is becoming more common place...for both CT and MRI...
heck, even i read sony is coming out with a new HD TV with 3d availability for some features... heck, even director james cameron has developed a new camera to film a 3d movie.
it would seem that that is where the value of the DViS and IMGG is herein... it would seem that a realtime 3d fluoroscope would have great benefit to the imaging world's "big brothers".
with respect to fluoro... here's a "can you imagine" scenario... can you imagine your orthopod having the technology to operate under realtime 3d fluoro and [maybe just having the radiologic technologist touching the screen to rotate the perspectives to view all perpendicular angles like many of these new phones have the applications to rotate the image by using your finger to scroll the "3d image."
from what i've heard/read in my dd, that is sorta how the DViS goes from one view to the other perpendicular view (which is an absolute must -- ortho means straight and orthogonal means right angle). of course, i've not read/heard anything in my dd, on the ability to do this by using a finger on screen... however, i believe the image may rotate like that via the operator... that would seem possible.
keep in mind though that current c-arms have touch screen features (not new), and that, again, in computer engineering, there is a trend on doubling computing power every 18 months. so who knows..."can you imagine" that... i can
all, IMO
