Please note the first sentence under "510(k)Clearance.
In regards to your questions pertaining to REE. I suggest you first DD and UNDERSTAND the concepts of kV and attenuation on the human body. You might want to look into mAs too, but that gets a little too technical. Then research levels acceptable in CT and fluorscopy. Then research the phrase "Imaging Gently" and its significance in the Medical Imaging sector.
I still don't understand why someone who doesn't understand the basics between 510(k) and PMA would want to invest in a company that is a make or break based on this. Let alone, why someone would invest in a company who doesn't have a basic understanding of the Medical Imaging industry. Sano, you may want to look for another stock to make money. I appologize if you have a short postition, then it makes all the sense in the world why you would post here.