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chevyman

10/25/10 3:28 PM

#30009 RE: drpolk #30008

Dr. That is indeed wonderful if that is true, thanks for the info!
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Boxsterfan

10/25/10 3:43 PM

#30014 RE: drpolk #30008

Last audit? You are kidding right?

1. There was an audit of the facilities for IMGG recently (August if I remember?). This audit had nothing to do with FDA approval other than keeping IMGG in good standing as a mfgr of C-Arms.

2. The FDA doesn't come to audit the facility for a 510K.

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mr_sano

10/25/10 3:45 PM

#30015 RE: drpolk #30008

Audit....are you speaking about the tidbit of info you released on yahoo about the FDA audit of Dean's facilities? By Dean own admission he said the 2 were unrelated. Doctor you really need to give us better intel than these measly scraps Dean is throwing out.

I have never seen any comparative data on radiation exposure and I have been asking the question for a while. Is it 1% of CT like we heard a while back?
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borntwice

10/25/10 4:25 PM

#30030 RE: drpolk #30008

This is false that they checked radiation output of the device.

Dean said on MoneyTV that the audit had nothing to do with teh device.

Simply false