GDSGDS, I know for a FACT the machine works.............
To other posters, please stop with the... "this has taken 3 and 4 years with the FDA".
I do not know why or what Mr. Janes was talking / submitting to the FDA about prior to 2010 But the device was only a concept until 2010
I am going to say one last time.
Per Mr. Janes on CC 8-19-09 at 2:59
After changing the platform to C or CC++Just started seeing the construct develop. This was Stage 2 of Development.
Stage 3 is plug in
Stage 4 is realtime
After stage 4 you can take all the images you want.
If the construct was just beginning to develop then the Dvis was not SC "substantially complete" meaning it could not be used for its intended purposes / can not do what the label says it can do. Furthermore you can not compare the Dvis to predicate devices without the images.
The actual images started to developed end of September 09. Mr. Janes tuned them up at end of January 2010. At some point between Jan and April 2010 achieved the wow factor he was wanting.
These images were reviewed/ compared to the predicate by two radiologist and were found SE.
At this point the device becomes SC "substantially complete" and can be used for its intended purposes thus ready to be found SE or NSE not AI. This does not mean the device was at final completion but it moves from concept phase to holy crap it works=SC.
The First complete 510k application with a working device was sent on April 5th, 2010
207 Days later found NSE Reasons UNKNOWN
Knowing that Mr. Janes did not have a clue what to put in the 510k app I am not shocked the Dvis was found NSE. You do not use a trial and error approach with a government agency. Dean was to busy trying to turn concept to "IT Works". With all due respect Mr. Janes is Engineer and software Geek not a 510k expert. He has never submitted a 510K that must be compared to two or more devices.
Going forward he would hire a big gun. When he does this the stock will go. This should happen soon. I hope before RSNA to help the PPS.
BUT Dean must NOT show the device! No one believes it works and that is just what is needed for a bidding war when SE is achieved. Dean wants the big boys to crap their pants in one day not over 6 months. IMO Dean wants to sell to big boys and must hit them with Granny's iron skillet.
Not many investors understand Dean Janes, the process, the events that has taken place, the order of these events, nor the things to come.
I will continue to buy all I can because the Device works. Never sold. Only buy. Always long
The ends will justify the means.
AI
