1) it works but the quality is poor and he doesnt want to show us lay people because all we will do is complain about the quality....he doesnt have the money (or the money is needed elsewhere) to get the horsepower to create clean crisp images that anyone can recognize as being good
2) he only has a working 2D machine and and the 3D gimic is on paper...his plan was to get approved sell company and let the buyer complete the last part of the equation on their dime
the flaw to #1 is why not get someone from the radiology world to review the machine and comment about how it works....none of us are gonna care if the image is poor if the third party (Radiologist, Periodical, University grad program, Blog) confirmed it did what was advertised...
that is why i believe #2 is what is going on.....#2 would explain not taking advantage of IDE...not showing the device in action, not seeking interviews with the media and getting NSE from the FDA (ie: we dont beleive it works and you have proven it to us either)
#2 might still be good enough to get approved...who knows...