Admiral, I'm not clear what your point is? No confusion here, I'm just saying...why can't a routine audit take place and data collected without it being a pre-clearance audit? Which, the FDA states they don't perform.
Yes this was a routine audit. One was performed by the state of California the other by the FDA. Was it directly connected to the 510K application? I don't know. Radiation output was tested twice due to such low output. I can only assume that due to the fact that this was a mfg audit that issues of safety and health compliance are routinely tested due to the fact that the Dominion does emit radiation. This was done in previous audits. The point I was addressing was one brought up by a previous poster that no approval would come without beta testing on radiation ouput. Excuse the slow response, I'm restricted to 2 posts per day. The point is that radiation output has been tested by a federal or state agency and emitted significantly less radiation than comparable devices.
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