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Tuesday, September 20, 2011 5:25:08 AM
The "quality" has to be equivalent to the predicate.
Also, the predicate has to be appropriate for the intended use. Dean can't just state that the 3d realtime imager's predicate is a plain vanilla x-ray camera.
IMGG has a long history of marketing statements that this will be used for surgery. The quality of the images must be spatially correct so that what the surgeon cuts is what is shown on the display.
Think of shaving with the side mirrors on your car. "objects in the mirror are closer than they appear to be". That is NOT spatially correct.
People lose sight over the fact that patients are Moms and Dads, and daughters and sons that can be harmed by devices that are approved without a rigorous and critical vetting. Would you want the DVIS used on your SPINAL surgery based on the claims of IMGG?
Paralysis is forever
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