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Tuesday, August 23, 2011 11:57:32 AM
Apart for image comparison analysis everything requested was like clarification .....that is what people linked to FDA thinks ....
That were it is taking time to present effective image comparison protocol.
You said you contacted some FDA consultant and they say it PMA ........I bet this was the case ....
DVIS is 100% 510k .....a slight change in intended uses doesn't mean PMA .....DVIS is a NSR (Non significant risk) device ....
This was confirmed by many people who are linked to either FDA or IRB (Institutional review board).
Guys and gals: There are many radiology institution .....contact those people and explain what you saw .....You will know what exactly you witnessed ....
As per one Guy:
"Invention of of cone beam CT had opened path for real time 3d imaging since last decade, but nobody thought of gantry computer - cart computer continuous geometry information message exchange to achieve real time 3d update .....IMGG filled a very broad patent to create real time 3d using cone beam system ,hence closing door for other manufacturer to enter into this space.
I believe IMGG will never ship any product post FDA approval ,they will be bought out for very handsome sum (minimum 600-700 M"
Believe or not ...DVIS is real deal .....
KKG
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