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yes images were QA (quality assurance), and remember they were pertinent to the CT (i.e., cone beam CT) feature only...as we understood from previous...
in the world of CT, the QA aspect is what an operator would do for documenting the units are calibrated to standards for quality control.
however, annually or biannually a medical physicist ensures high/low contrast (among other batteries of tests, referred to as physics acceptance standards), and annually companies do PM, i.e., preventative maintenance.
i take the actual requested images (now old news, as they were submitted and now the FDA just wants to finalize labeling) this to mean that the FDA took the CT component seriously.
by the way, both acceptance testing and PMs are done in fluoro too. so the same concepts would apply to the fluoro features. QA as far as imagery isn't really necessary for daily/weekly performance in mobile fluoro...
the concepts of these tests are to provide objective data (both for the FDA and for the real world ultimately upon clearance), and is why patient or clinical images aren't necessary.
thanks for writing up the synopsis...
computer aided detection (CAD) is not what the DViS does...in layman speak, it is software which looks at images and looks for patterns which then, if necessary, flag the image for the likelihood of disease...
thus, it is a diagnostic tool...or shall i say an add-on or advancement in diagnostic imaging... the buzz on CAD has been associated mostly with detection/screening of cancer in mammography.
a way to imaging this, picture yourself laying on the ground in the forest and looking up into the trees...trying to view the sky...all the branchings of the trees are mingled and criss crossed and the branches look like thousands of cross-fingers or arteries (like vascular nodular tissue)...and then imaging that there are bright patches of the sky penetrating through the canopy where there is an area or two or so of hardly any tree branches and so on...(by the way, the contrast between the bright background sky and dark branches in this analogy is the ***contrast*** in the image)... however, you are trying to find where the sun is located... remember it's pretty clustered rhrough the canopy as you look up and perhaps the sun isn't so easy to note compared to some of those bright spots in your 'region of interest,' and perhaps the sun is dimmed by being behind some clouds, etc.... well, CAD would look at this picture and locate the sun for you... or in other words, give the radiologist a tool for focus in on a specific region...
what CAD is really doing i believe is looking for fractals (this is a mathematical pattern)...
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now what the DViS is gonna be all about is serving as the next generation "c-arm" for fluoro-guided surgery/procedures, by providing 3d realtime imagery.
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i'll also note that the other part of that advisory committee mtg is going to discuss mammography... mammo i extra highly regulated...
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and lastly the ability for the modality to produce those images and thus inherent contrast is tested (by physics acceptance testing)...this is refered to as high/low contrast imagery. but, that is completely different that CAD...
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the requested images which were sent was probably a combination (in my speculation) of images and the tests results of high/low contrast...the test is routine and done either biannually or annully, for our c-arm and its application, it's annually. to give the FDA some objective data.
Cone beam CT and a review of portable CT scanners: nice relevant info.
two recent issues and the current issue of the american journal of neuroradiology contain three relevant articles:
two on CBCT...
Conebeam CT of the Head and Neck, Part 1: Physical Principles
http://www.ajnr.org/cgi/reprint/30/6/1088?maxtoshow=&HITS=60&hits=60&RESULTFORMAT=&fulltext=three+dimensional+fluoroscopy&andorexactfulltext=and&searchid=1&FIRSTINDEX=0&sortspec=relevance&resourcetype=HWCIT
Conebeam CT of the Head and Neck, Part 2: Clinical Applications
http://www.ajnr.org/cgi/reprint/30/7/1285?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&searchid=1&FIRSTINDEX=0&minscore=5000&resourcetype=HWCIT
as well as on a review of portable CT scanners...
Review of Portable CT with Assessment of a Dedicated Head CT Scanner
http://www.ajnr.org/cgi/reprint/30/9/1630?maxtoshow=&HITS=60&hits=60&RESULTFORMAT=&fulltext=three+dimensional+fluoroscopy&andorexactfulltext=and&searchid=1&FIRSTINDEX=0&sortspec=relevance&resourcetype=HWCIT
so, the way i read this is: when the dominion is cleared by the FDA.
1. DEFINITELY A MARKET FOR THE DOMINION'S CT FEATURES: NOTED HERE ARE APPLICATIONS PERTAINING TO THE HEAD AND NECK AND/OR ENT.
2. ADDED TO THAT: A NEW/UNIQUE FORM OF FLUOROSCOPY, WHICH ONLY THE DOMINION BRINGS TO THE TABLE.
3. NEW/UNIQUE IN SUCH A WAY THAT THE FLUOROSCOPY IS NOT ONLY REALTIME, BUT REALTIME 3D. FORGET ABOUT MEDTRONIC'S O-ARM.
4. UNTIL THE DOMINION, REALTIME 3D HAD NEVER BEEN DONE BEFORE: oh and add to that, 'digital subtraction' for angiograms and replay features...
again, please keep in mind...the journal cited has a target audience aimed at head/neck and or ENT physicians, thus...DOMINION'S target audience is more wide spread, as IMGG'S DOMINION CAN SCAN ANY BODY PART.
also, keep in mind that as i understand it the Stark Law does not apply to mobile devices, therefore a big plus for smaller centers/offices.
plus, the price is comparable to the above scanners.
again, i think the FDA is taking the DOMINION's CBCT features seriously -- as that is my inference from the high contrast CT images request, which i really in my opinion were to ensure that such images meet physics acceptance testing standards.
three personally and one when he worked at toshiba...
here's one when imaging3 was imaging services...
http://www.accessdata.fda.gov/cdrh_docs/pdf/k010772.pdf
DViS will be his 5th.
madtig actually this one which is yours works better...
http://stockcharts.com/h-sc/ui?s=IMGG&p=D&yr=0&mn=4&dy=0&id=p14409094838&a=179212375
sorry this is his reply...i linked the question...
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=15253336
i don't really understand your assumption, just by first glance, based on my experiences, these are images obtained from a CT scanner...this is what a post-processed CT image looks like...you can virtually strip away layers...read my post (link below) from yesterday about "trends in 3d CT postprocessing." i've used such images in powerpoint presentations. acutally what happens is that the CT scanner is able to assign a level of contrast to different parts of the body...based on Hounsfield units. this forms the basis for the construct to 3d when postprocessing.
see...
http://en.wikipedia.org/wiki/Hounsfield_scale
and note who Hounsfield is...
http://en.wikipedia.org/wiki/Godfrey_Newbold_Hounsfield
"trends in 3d CT postprocessing...
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=42188278
what i mean in posting this is that 3d postprocessed scans have increased (yes they are render later after such scans/exams)...the data proves it... thus, one would infer that if any imaging device (which does 3d imaging in real-time) would gain FDA clearance, then one would imagine that there would be such a market for such a device.
particularly taking into account that the purpose of said device would be that of a fluoroscope (which is used by physicians in real-time during procedures) with cone-beam CT capabilities...
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This is an interesting post too...more for my reference later though..."Converting CT Data to Hounsfield Units."
http://www.dfanning.com/fileio_tips/hounsfield.html
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now, let's look at an older post by dean here...read this and then the one for which it is in reply too...sorta more interesting and sorta along the lines of the model/concept related to what you posted...
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=15253266
trends in 3d imaging...
http://radiologictechnology.org/cgi/content/abstract/81/1/24
Radiologic Technology, 81:24-31 2009
Trends in 3-D CT Postprocessing
LAURA PIERCE, MPA, R.T.(R)(CT), JARRETT ROSENBERG, PhD and SANDRA NEUSTEL, PhD
Purpose The increasing number of multidetector CT scanners in radiology departments has intensified demand for 3-D imaging. This study sought to reveal the frequency and type of postprocessing tasks being performed by computed tomography (CT) technologists by discussing the longitudinal results of the American Registry of Radiologic Technologists (ARRT) CT practice analysis surveys from 1993 to 2007.
Method In 1993, 2001 and 2007, the ARRT mailed CT job analysis surveys to a national randomized sample of 1000 radiologic technologists per year who were employed full time in CT, for a combined total of 3000. A usable sample of 1476 responses from the 3 surveys revealed technologists’ level of responsibility for a variety of CT tasks, including 3-D imaging.
Results The proportion of respondents responsible for 3-D imaging increased from 47% in 1993 to 74% in 2001 and to 82% in 2007 (P< .001). This increase occurred in all employment settings (P < .001) and department sizes (P < .001), including small departments. Daily frequency of occurrence grew from 4% in 1993 to 11% in 2001 and 53% in 2007 (P< .001).
Conclusion Routine 3-D postprocessing has become typical practice in radiology CT departments across all employment settings.
thx chevyman. eom.
thx to those who replied, i couldn't open the link... but didn't know their was a dispute... maybe someone could summarize it or if it's not important then then maybe not... at any rate, does any feel as though the essence of my original post on this thread is correct... that there are in-roads laid accordingly. thx again...
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
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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
madtig so what do you think about it maintaining itself at the 38% fib retrace per your chart in the post i'm replying to.
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?pageNumber=2&verify=0
i haven't sold any of my .035 and .031 collection because of this exact reason...this is seed money... i fully can appreciate the paradigm that the dominion can shift...
i don't concur that those comments have anything to do with the price drop...the thing ain't gonna keep going up or remain level while we move along toward 510K clearance, it's gonna go up and down...maybe if the pps had already been in an established range and the comments were overt and not in response to some yahooligan not dropping the topic...and again dean was just trying to cut him off to go on to the next caller...in addition, i actually never heard him state that they would even pursue other countries if not approved...the person who posted the unofficial thread stated something like he had stated that...he merely stated the locations were there aren't any regulatory issues to have to surpass i believe. he remained steadfast in the direction to get FDA approval first...
meant to say he stated the things like you mentioned in the post i'm replying to in order to pacify them...to move on to the next caller...
impaidbyu, what do you mean --- i think dean showed confidence during that call...was rattled most by the fact that the spaces available were limited...but dealt with it accordingly, as he does in his dean style...and then by, i think two callers, who bombarded him about the "what if's." it was quite frankly annoying that they kept prodding like they did. i felt as though they were recent run-up newbies...just by my take by how they poked... that was when he stated the things like you mentioned in the post i'm replying to... HOWEVER...he also stated that it was in the company's mission/vision statements to go with the US markets first...and he stood firm on that...i support that wholeheartedly too...he stated i'm paraphrasing that it would be logististically best to do so... so...all in all...i wished i could have called in but was in cases that day...however, most of my questions would have been on the basis of dean's replies to "Doc" found here in that ibox thing... i was interested in asking him to talk about the actual practical aspects of how the device runs...is there subtraction...replay...yadda yadda...great answers...i wish i could make it to RSNA but will be at NANS during that timeframe as of right now...