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IMGGorBust

10/01/10 9:21 AM

#28262 RE: adrian taylor #28247

My gosh, I just read it, and there's a big section on Magnetic Resonance Imaging; i.e., MRI. Do you think Dean is trying to tell us something? Do you think the DViS is really not a RAD device, but rather is really an MRI device? It's in the 10-K, so that must be it! Or maybe it's just like he says, here's some background about the industry and the FDA. Seems pretty generic to me, almost like it's boilerplate for 10-Ks in this industry, but you must know better than the rest of us the way you talk with such certainty.
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vinovista

10/01/10 9:40 AM

#28264 RE: adrian taylor #28247

I would suggest you read or reread the 10k. But wait let me help you.

Class III devices are usually those that support or sustain human life,
are of substantial importance in preventing impairment of human health, or which
present a potential, unreasonable risk of illness or injury. Examples of Class
III devices which require a pre-market approval include replacement heart
valves(implanted), silicone gel-filled breast implants(implanted), and implanted cerebella
stimulators.

I ask again what part of Dominion do you think will be implanted!!!