Who told you there were? How is possible for you to say it worked 100%. You didn't attend? Frankly it's all subjective thats why DVIS needs clinical testing. There is no getting around it. Whether they can force it through the 510K process is still a big question and not a given by any standard. THe FDA believes 3d fluoro is a new indication and there is PMA.
IN any event advance the SANOclock says a minimum of a year. Look for a resubmission 2q 2012 with an answer on about RSNA2012. Sound familiar? BTW 1 year will require 1.4 to 1.8M additonal cash.
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