Imaging Diagnostic Systems (fka IMDS)

[LongnShortOfIt]

RIght. 8 years since they had a PMA application in front of FDA. And, that took over 4 or 5 years to get that far!

In their latest attempt, they claimed to have a "draft PMA" but never submitted, opting instead to try the 510(k) route which ended in FAILURE too last August.

So the question on the stand would be where the 'draft PMA' got to? Why wasn't it filed?

Subsequently, they've volunteered in their SEC filings that they knew since Spetember 2008 they did NOT have enough scans. How can you write a 'draft PMA' if, by your own admission, you KNEW you didn't have enough scans to write a 'draft PMA' in the first place??

Not washing.