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Re: IMGGorBust post# 10383

Tuesday, 02/09/2010 9:18:52 PM

Tuesday, February 09, 2010 9:18:52 PM

Post# of 59551
Little to nothing in terms of utilization is absolutely correct since there is no alternative as of yet. I'm an ER doc and during a very busy 12 hour shift I can easily order 30 plus CT scans. In today's world of defensive medicine they're a must. The questions I believe the FDA are asking go beyond your radiologist friend's comments. Because of all the recent hype over the high levels of ionizing radiation emitted I think the FDA is focusing with special intensity on this 510(K). They may be focusing on the company claim that dominion emits significantly less ionizing radiation on average. And if Imaging3's claim of less radiation emission is true, are the images still as good?
But I agree with Mr. Janes that image quality is a market driven issue and not one upon which FDA approval should depend.

Disclosure: Long IMGG.