Grapefruit USA Inc (GPFT)

[BennyJ]

I don't know that. I believe this recall for Breakaway imaging's original product(2006 approval). Medtronic bought Breakaway(I think Sano will jump in here since Breakaway was bought out for poor money)
if you carefully look at the recall notice, they stated the month of May this year, but actually got another upgraded version's clearance in June.
But my point is that if they do a recall on one product, it doesn't mean that FDA will have to recall all the other products they cleared based on that product as a predicate.

So Answering to your question, even though if medtronic o-arm imaging system is used as predicate in DVIS application(Dean only knows about this which one he used as predicate for each modalities), it doesn't matter as long as it matches the characteristics(safety & effectiveness of the predicate at the time of predicate's approval/clearance)

Hopefully this clears your concerns.

Here in the below link type device name section as O-ARM IMAGING SYSTEM AND SEARCH. YOU WILL SEE 3 and do your research

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm