Grapefruit USA Inc (GPFT)

[goldcoastoh]

As many know, i'm excited IMGG...i'll provide a recent post of mine (below - below the 5 asteriks)...but per the most recent cc they were mentioning more about producing the DViS, upon clearance, in the u.s. at their facility...than mentioning any overseas stuff...granted the overseas plan has been stated before--and it has been per my recollection, korea, that was stated--so what came up about production in the call was more or less new news... now, on the premise the DViS is approved soon, then what about those overseas comments and what about this, my so-called "six degrees of separation," with the Medison company, out of korea, named in the 2001 clearance letter for an earlier 510K cleared product (link below to clearance letter per my post below the 5 asteriks).

by the way, today the Medison company is in the main biz of sonography equip per an online search. however, such that my online search brought up the same named company per the 2001 clearance letter...although that doesn't mean that Medison doesn't have the ability to produce c-arms at some plant... because they aren't an american company listed i didn't bother to look for any regulatory filings to get a better grip on them...

http://www.medison.com/eng/index.asp

(and you don't have to install the korean language thing to bring the page up...just hit ignore...each time when i bring up the page it asks me twice and i simply click ignore twice.)

bottomline, more than just speculating about overseas manufacturing capbilities/connections, what i'm saying is that there is definitely a foundation for the overseas manufacturing comments based on earlier product/devices.

but let me digress on something somewhat similarly related--as to the CCD device/camera. while the post below provides info...here's an excerpt from the Form 10KSB filed 04/10/06 for the Period Ending 12/31/05... under history... "In early 1994, Imaging3 began offering upgrades for OEC C-arms. The most successful upgrade was a CCD (Charged Coupled Device) camera, which improved image quality of older systems comparable with that of brand new products. This offering became so successful that the Company integrated this upgrade with used OEC C-arms and built custom units for NASA, Harvard, University of California at Irvine, University of California at Davis, Baylor University, Baxter Healthcare and other prestigious healthcare organizations. Later that year, Imaging3 applied for and received FDA approval for this device described as the NASA II CCD C-arm." and i'll add...the OEC 902 NASA II CCD C-ARM.

now, about the prolonged clearance process...i dunno, but my sense is that more than the first real-time 3D imaging/fluoroscope, the FDA is taking the essentially 16-slice CT capacity of the DViS seriously...obviously yes, they would...but, what my sense is that it cleared the fluoro feature and now they are only looking at the CT aspects of the DViS...now, remember, this doesn't mean that the DViS will be replacing the CT equipment of the today...64 slice (maybe 32 slice) would may be the entry level from equipment makers...with 128, 256, out there and dual x-ray tube CT out there too...

i've stated before, Moore's law, about doubling of computing power every 18 months...so who knows if there would be potential to increase the slice capacity of the DViS down the road

but...while on the topic about CT, i understand (per the cc call) that once the DViS is approved that IMGG would/can submit for a vertical application of the product...meaning load-bearing CT...i find that perhaps the most intense thing about the CT aspect of the DViS...that ain't been done and there are already "load-bearing" MRI equip out there... IMGG chose not to include that part of their plans in the current FDA submission because it would "muddy the waters" with respect to the 510K and thus perhaps make the FDA process even more time-consuming for an initial application clearance... after-all, weight-bearing/load-bearing exams aren't that exotic, as they are common-place for radiography (meaning x-ray type) exams... so i'd imagine that such a CT application would welcomed in the community.

LASTLY, before my post below...i can't impress upon you how truly big the RSNA (radiological society of north america) meeting is, figuratively and literally...some 80,000 participants if memory serves me correctly...take a look at the pic at the top left corner of the annual meeting page...

http://rsna2009.rsna.org/preliminary_information.cfm

and here's the floor plans for the exhibitor hall...

http://rsna2009.rsna.org/floorplan/default.html


*****
i know dean has stated (recent cc's) that he will produce the DViS here... however, he has also stated he has set up some aspects of manufacturing overseas...i think his 1st cc stated, korea...

pieces coming together... he ain't blowing smoke... he most definitely has in-roads laid...

remember he has been instrumental in developing the CCD camera for fluoroscopes...

and has prior 510K experience...

read this clearance letter for one of those 510K clearances...when imaging3 was imaging services.

pay attention to the second paragraph...

http://www.accessdata.fda.gov/cdrh_docs/pdf/k010772.pdf

just my two cents on some deductive reasoning for my dd.

but here's some more...

take a look at this article on it...3rd paragarph.

and note the title, "...FDA works through a backlog of submissions." some things never change huh...

http://www.diagnosticimaging.com/radiation-oncology/article/113619/1218772?pageN\umber=2&verify=0