Is that what I said? Did I say there was a typo in the FDA's letter? "Comon" man, my post was only two sentences.

Of course, if you listened to the conference call or read others' posts, you'd know that the fax was received near the close of trading Thursday afternoon. There was a typo in the 8K that will be corrected.

No, what I posted is an accurate account of what Dean said. Now if you believe Dean was lying on the call, that's for you to decide, but my recitation of what he said is accurate.

Absolutely.

Did you hear something different?

Summary of the Conference Call:

November 1, 2010 Imaging3 Conference Call:

Immediately before the Conference Call, Imaging3 issued an 8K announcing that the 510(k) application for the DViS had received an NSE determination from the FDA (essentially a "rejection"). During the call, the CEO described the correspondence from the FDA and set forth the plan going forward.

• FDA informed us that our product was not substantially equivalent to the devices included in the 510(k) application.
• The CEO is extremely upset with this, because the basis of the decision appears to be "ridiculous," for example, they said we did not file certain financial information, which they didn't ask for.
• At this point, we have several avenues to file, and one thing is for certain, we're going to hire a consultant and/or legal counsel to either appeal the decision, re-file or file a Third Party Review.
• From a timing standpoint, he expects to make a decision about who to hire, what avenue to follow, and have that path started (i.e., a new application or an appeal document in the hands of the FDA) within 30 to 60 days.
• Due to the fortuitous timing of bringing in an institutinal investor recently, which provided for substantial funding of the company so we can easily afford to seek outside help.
• The CEO will utilize any resource at his disposal to get this product through FDA to the market. The gloves have come off.
• He described the rejection as "administrative" in nature. The majority, if not all questions, were about how the package was put together. There was not one question about safety or the technology. There was one issue identified with the label (but we copied the label from the predicate devices). The rejection appears to have been based on a lack of financial information in the package, issues with the level of detail describing the software, and an issue with image format, but the FDA did not report any concerns about safety and image quality.
• Dean is also much more open now to exploring other markets while we await FDA approval now, including having the device placed in test sites, provided that would not muddle the waters with the FDA.
• Dean is also much more open now to publicizing a demonstration of the 3D real time functionality, but probably not in time for the RSNA.

Approvals are handed down every business day. There tend to be more on Thursdays and Fridays, but not by a huge margin. The way the Conference Call appears to be have been hastily scheduled, suggests to me that whatever news Dean has, he just received this afternoon. He also said he wouldn't play any games with the timing of the announcement of Approval. When he got it, he would get it in the hands of his lawyer and get the announcement made within a couple of hours. That's what this feels like.

I find the timing of the call and the short notice between the announcement of the call and the start of the call most interesting.

Could it be that the fax or call from the FDA came in and was immediately sent over to the lawyer to work out the final language of the PR. In the meantime, a conference call to talk about what comes next (and to gloat a little) was set and announced while the PR is being finalized. PR is issued between 4 PM - 5 PM, then the conference call. Could be, and could be very interesting.

Here's hoping.

Free at last, free at last, thank the all mighty moderators, I'm free at last. Folks, no offense, but I can't say I've missed you at all. The really sad thing is, I sat on the sidelines for an entire month and didn't see a single piece of new information, a single new "argument against" the value of this investment, or anything that really needed a response. It made me realize how useless all the time I had spent here knocking down straw men had been.

The facts remain the same: Dean invented a breakthrough medical imaging device for which he obtained a strong patent that will not be crossed any time soon. The device works as advertised and is ready to go into luminary sites and used on patients in a real time 3D modality immediately upon FDA clearance. Upon clearance from the FDA the PPS goes to the moon. There is no longer any immediate or even mid-range risk that Dean cannot fund the Company while we wait for the FDA, as we now have serious institutional investors betting big in favor of success. We have a new FDA that has loosened the grip against radiation emitting devices. We have a review process that is painfully slow, but at least now it's not being delayed by inexplicable AI requests or requests for any information whatsoever. Now, the application is entirely in the FDA's hands with everything they've asked for, including performance data in the form of glowing reports of SE or better from at least two expert, third party radiologists, which is the very last piece of information the FDA asks for in its flow chart to Clearance. We are engaged in a confidential process with the FDA that limits what applicants report to the public (so no applicant will ever reveal the specific questions asked by the FDA in an AI request) and limits the nature of the marketing in which an applicant can engage. All that makes it easy for some to whack at Dean like a piñata because they know his hands are tied. All we can do is patiently wait for word from the FDA, which I found in the last month was much easier to do and was much more relaxing without coming to this site very often.

I remain long and strong, and load up on every dip (thanks for the .22 shares whoever you are). I hope we have word from the FDA before RSNA, but if we don't, we don't. As long as the application is in the FDA's hands and we don't have an NSE, the good word could come any second. I'm out of the business of predicting dates, because with RAD devices, the general principles just don't seem to apply. The FDA will work at its own pace, but it could be any day, and that's why I'll continue to load up every chance I get.

As for the recent discussion about Dean contacting the muckity mucks at the FDA, here are my thoughts. People are really getting worked up about this, and there are two schools of thought. One is the squeaky wheel gets the grease. The other is, the annoying whiner gets dropped to the bottom of the pile. I think neither is true. Bureaucrats may often be lazy and ineffective, but they are not vindictive. They are not going to punish a businessman for looking out for his own business interests. They're also not likely to be scared, intimidated or sweet-talked into acting any faster. So the net result of a contact from Dean to managers at the FDA will be nil. However, I am always in favor of having more information versus having less information, and higher level contact at the FDA could result in Dean having a little bit more information about where in the process the application stands and what he should expect going forward. That information could help inform his business decisions like when and if financing is necessary, when and on what terms to form partnerships, etc., so it can't possibly be a bad thing. In other words, I don't think people need to lose their minds about it because I don't think it will change the outcome or the timing of the outcome, but I do agree that Dean should be more assertive with the FDA. If he is getting nothing but cryptic "it's under review" responses from the Reviewer, it's time to go up to the next level and see if he gets any more useful information. It can't hurt. The fruit falling on your head from shaking the tree argument is wrong. But so is the argument that making the call will save the day.

In sum, nothing has changed except we are a month closer to FDA clearance than the last time I posted. I wish I could say it's nice to be back.

Oh, and for those asking for more communication from Dean, and "wishing" for at least a monthly update, that's exactly what he gives us. Check the timing of the last update he gave on MoneyTV... it was just 3 weeks ago.

The FDA's 510(k) review process has been cofidential throughout, and is confidential for all applicants throughout. Dean has provided general context about what is going on without crossing the line, just like he did with the most recent questions from the FDA. He described a general issue with the label last year, but we don't know what it was specifically, because he's not allowed to say. We knew about the 17 questions that were mostly repeats and basic mechanical and hardware questions, but he is not permitted to recite to the public what those questions were specifically. We knew generally about the Radiologist Report but he wouldn't tell us anything specific about it. He shared the same general level of information with us about the recent back and forth, i.e., couldn't open a file or two, and didn't understand why certain data that was not typical of 510(k)'s was included in the package. He has been as open as he can be, and for that I'm greatful. If you think he has been more specific about past questions, please show me specifically where he has done that. I'd like to see the list of previous questions that we know were asked by the FDA.

Also, we keep hearing that Dean is requesting additonal shares to raise cash, but nobody can explain why he hasn't touched the 125,000,000 authorized but unissued shares that already exist. His actions speak loud in that regard.

It is also absolutely 100% false that Dean refuses to allow any experts in the medical field or media to look at the product. We know that there are at least 5 NDAs signed by other major players in the industry so that they can take a detailed look at the product.

I'm really confused about the warnings over the past few months that Dean is chomping at the bit to issue more shares to either stave off bankruptcy or to some how line his own pocket, and, heaven forbid, dilute for the sake of dilution. Yesterday, the Company filed with the SEC a Form S-8 POS that states: "The authorized capital stock of the Company consists of 500,000,000 shares of Common Stock, no par value per share, and no shares of Preferred Stock. On September 24, 2010, the Company had 375,790,511 shares of Common Stock issued and outstanding and no shares of Preferred Stock issued and outstanding."

So Dean has had 500,000,000 authorized shares but only approximately 375,000,000 issued for more than a year now. He has had at his disposal 125,000,000 authorized but as of yet unissued shares at his disposal and he hasn't touched them, hasn't sold them, hasn't done a PPM to raise capital with them, etc. He has left them alone. If he has had 125,000,000 shares that he could issue any time he wants, why should we fear that he wants to authorize (but not issue) more shares now for any reason other than what he has said publicly and repeatedly (for a poison pill), especially in light of his actions vis-a-vis the 125,000,000 he has had access to for more than a year? I'd say Dean has earned some credibility by not touching those shares.

I don't understand. You have been telling people that the indicators look weak and that they should set stop losses (i.e., sell), and you didn't tell people that you had sold your shares, and somehow that's better?

Well, what are you suggesting people do when the PPS hits or crosses a stop loss? You just said holding was only prudent in a religious setting, so you're saying everyone should sell, aren't you?

My gosh, I just read it, and there's a big section on Magnetic Resonance Imaging; i.e., MRI. Do you think Dean is trying to tell us something? Do you think the DViS is really not a RAD device, but rather is really an MRI device? It's in the 10-K, so that must be it! Or maybe it's just like he says, here's some background about the industry and the FDA. Seems pretty generic to me, almost like it's boilerplate for 10-Ks in this industry, but you must know better than the rest of us the way you talk with such certainty.

And I'm telling you that I looked at your link, and despite what you're saying, I see not a single example of them reciting the questions that the FDA asked them. When you ask me for examples or specific data, I provide it, that's how I've earned credibility on this Board. I'm asking you to do the same.

Regardless, talking about MELA is a poor example because they are going through the PMA process, not the 510(k) process. PMA is naturally a more public process because it involves public trials.

I've poked around, and I just can't find anywhere they recite the questions the FDA has asked them. In any event, it's not a 510(k) process they're going through.

Anybody can list company names, but how about a link to where their CEOs recited the exact questions that the FDA asked them during the process or produced to the public copies of their correspondence with the FDA during the process. I'd settle for just one.

Microsoft, Apple, Dell, McDonalds, Pfizer. See, I can do it too.

That's an interesting thought, gdsgds. Can you provide me a link to a single other company in the United States in the entire history of the 510(k) clearance process at the FDA that has produced to the public its correspondence with the FDA during the course of an ongoing 510(k) review process? Show me a single example, just one, where the CEO of a company going through the 510(k) process has produced or recited the exact questions asked by the FDA in an AI Request. It is a confidential process, you know?

The 10-K provides a really nice history of the Company and description of the intended uses included in the DViS 510(k) application, and represents yet another sworn statement by the Company of the existence and capability of the DViS. It's a must read. Here it is for your convenience:

HISTORY

The Company was founded as Imaging Services, Inc. ("ISI") on October 29, 1993, by Dean Janes. The Company initially served as a low cost, third party service alternative for equipment made by Orthopedic Equipment Company Medical Systems ("OEC"). OEC is the largest manufacturer of mobile surgical C-arms with over a 60% market share in the United States. A C-arm is an integral component of a fluoroscopic imaging system used for various types of surgery. Management believes that prior to the Company's inception, no company existed solely focused on providing third party service for OEC equipment.

In early 1994, Imaging3 began offering upgrades for OEC C-arms. The most successful upgrade was a CCD (Charged Coupled Device) camera, which improved the image quality of older systems to be 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 United States Food and Drug Administration ("FDA") approval for this device, described as the NASA II CCD C-arm.

In mid 1995, Imaging3 purchased the assets of ProMedCo. ProMedCo had an exclusive agreement with OEC to remanufacture OEC C-arms for OEC Medical Systems. Though the purchase did not transfer the agreement, it eliminated one
of the Company's competitors and provided a substantial inventory of replacement parts. Access to these replacement parts allowed Imaging3 to increase immediately its production levels and created the opportunity to remanufacture OEC's complete product line, thereby increasing the models ISI could offer its
customers. Also, this purchase allowed the Company to enter the lucrative parts sales business.

In 2000, the Company continued its expansion by purchasing a sales company in San Diego, California. This asset purchase brought an extensive database with the contact information for over 43,000 physicians, hospitals, medical centers and surgery centers as well as a streamlined automated sales force. Also, as part of this expansion, several key employees, most of whom were former employees of OEC, were hired to increase the Company's service presence in Arizona, Washington, Nevada, Florida and Hawaii with a national service
presence as the ultimate goal. In 2002, the Company closed the San Diego office and consolidated operations in Burbank, California.

On February 19, 2002, a fire gutted the Company's principal operating facility, causing an estimated $4.3 million in damage. The 10,800-square-foot structure was subsequently rebuilt and the Company has reoccupied it. In the interim, the Company leased temporary facilities. The damage to the building and the loss of the Company's equipment were partially covered by liability insurance. Nevertheless, the fire disrupted the Company's operations.

In order to better position the Company for its future direction away from service and toward providing proprietary medical imaging products, the Company changed its name Imaging Services, Inc. to Imaging3, Inc. on August 20, 2002.

On November 25, 2009, the Company filed with the FDA a 510(k) application for approval of the Company's medical diagnostic imaging device for sale in the United States. Assuming that the FDA grants approval, the Company intends to follow up and apply to sell the product in the European and then
worldwide markets. The FDA is currently reviewing the application, and management is not certain if or when FDA approval will be granted. The Company completed building its first prototype medical diagnostic imaging device in
April 2007.

BUSINESS OPERATIONS

Imaging3 technology has the potential to contribute to the improvement of healthcare. The Company's technology is designed to cause 3D images to be instantly constructed using high-resolution fluoroscopy. These images can be used as real time references for any current or new medical procedures in which
multiple frames of reference are required to perform medical procedures on or in the human body. Management believes that Imaging3 technology has extraordinary market potential in an almost unlimited number of medical applications, including:

o TRAUMA CENTER. Imaging3 technology would allow a surgeon to immediately view exactly where a bullet is lodged in a gunshot victim. At any point during the procedure, the surgeon could continue to view 3D images in real-time.

o CARDIOLOGY. Imaging3 technology could provide a 3D view of a heart and allow a cardiologist to record the heartbeat in real-time. The entire heart would be visible, including veins that are wrapped around the "back" side.

o PAIN MANAGEMENT. Imaging3 technology could provide a 3D view of the spine, nerve endings, and injection points and help guide the needle for spinal procedures. 3D images in real-time could also be used to view disk compression.

o NEURO-VASCULAR. Imaging3 technology could provide a 3D view of the skull and brain to diagnose neuro-vascular diseases. 3D images in real-time could be used to view the rupture of vessels or arterial blockages diminishing blood flow to the brain.

o ORTHOPEDIC. Imaging3 technology could provide a 3D view of bones and joints to help diagnose orthopedic conditions. An orthopedic surgeon could view a 3D image in real-time to line up a screw with the hole in a hip pinning.

o VASCULAR. Imaging3 technology could provide a 3D view of veins throughout the body. After injecting dye, a 3D image in real-time could pinpoint clots and occlusions and help diagnose vascular diseases.

MULTI-FUNCTION DEVICE

A diagnostic medical imaging device built with Imaging3 technology can perform several functions and can replace or supplement a number of exiting devices, resulting in considerable cost savings for hospitals and healthcare
centers. These functions include:

o Perform real-time, 3D medical imaging;
o Emulate a computerized tomography ("CT") scanner (at a fraction of the capital cost); and
o Perform standard fluoroscopy.

The Company's management believes that this multi-function capability will be especially attractive in foreign markets, where the cost of a CT scanner is beyond the means of most hospitals and healthcare centers.


PATENT

On June 23, 2004, U.S. Patent No. 6,754,297 was granted in the name of Dean Janes, entitled Apparatus and Method for Three-Dimensional Real-Time Imaging System. The rights to this patent have been assigned to the Company.


ABSTRACT OF THE PATENT DISCLOSURE

A computing device in a three-dimensional imaging system utilizes a plurality of distance readings and reference readings from at least one subject sensor to determine a subject location and a subject volume and establish a base three-dimensional map of a subject. A plurality of two-dimensional image exposures along with a plurality of associated reference locations are created by rotating an image source and an image receptor around an inner circumference of an imaging gantry. The plurality of two-dimensional image exposures is digitized to create a plurality of digital two-dimensional image exposures. The
computing device receives the plurality of digital two-dimensional image exposures and the plurality of associated reference locations. The overlaying, interpolating and pasting of the plurality of digital two-dimensional image exposures on the base three-dimensional map creates a base three-dimensional image exposure, which is displayed on a display device.


GENERAL DESCRIPTION

Real-time 3D medical diagnostic imaging will be accomplished by scanning the patient, either partially or completely in a 360-degree circumference under fluoroscopy (or other type of image exposure), utilizing a
single or multiple x-ray source and image receptor. The information acquired under fluoroscopy (or other type of image exposure) will be digitized at a frame rate of between 30 to 60 frames per second. This information will be sent to a computer system to be incorporated into a three-dimensional image to be displayed on a computer monitor. The image created can then be manipulated and/or rotated to view the scanned image of the patient's anatomy in any direction or orientation desired by the user. The user could then choose a
specific area of the image to update. Once an area is selected, the computer displaying the image would then "gang" or align the x-ray source(s) and image receptor(s) to begin updating scans of new images to be overlaid upon the
existing three-dimensional model. This process would then be updated and/or repeated as many times as necessary for the specific procedure to be completed.

At any time, a new reference area or scan could be selected or initiated.

THE "O" DEVICE

Part of the Company's invention is based on an "O" device to create a circular gantry similar to that used with CT to scan a patient a full 360 degrees with fluoroscopic radiation. This approach is expected to allow imaging of the patient from any frame of reference or angulation (current medical
imaging devices are limited to 150 degrees to 360 degrees with mechanical orientation or manipulation). 3D imaging requires an "O" device to scan the patient in increments of 360 degrees to allow construction of a three-dimensional image. By scanning the patient in 360 degrees and acquiring images at 30 to 60 frames per second, management believes a three-dimensional image can be constructed.


IMAGING3 TECHNOLOGY DIFFERS FROM OTHER APPROACHES

The "O" device approach is similar to that used in a CT scan. The difference is CT is used to image a "slice" of the anatomy and not intended for real-time fluoroscopic imaging. The slice is obtained by using a fulcrum reference point and rotating the X-ray source and image receptor in reference to
that point. This basic geometry creates a 2D image in any depth desired, in any region of the body. The "O" device would use a similar fulcrum point to reference depth, but the scan would not create a slice but instead a real-time image captured at 30 to 60 frames per second in 360 degrees. Further, management
believes that the "O" device would be used for conventional fluoroscopic imaging with the advantage of positioning the X-ray source and receptor at any angulation desired.

Currently, 3D imaging is used only for reconstructive post processing reference images. Magnetic resonance imaging ("MRI"), CT and ultrasound currently have this capability. The 3D images are created by multiple scans of 2D images that require a long period of time to process into a three-dimensional
image. The image created is then used only for reference, not real-time manipulation in the body. The Company's 3D images will be constructed almost instantly and will be available to be used as real-time references whenever multiple frames of reference are required to perform medical procedures on or in the human body.


DIRECT COMPETITORS

At this time, the Company is not aware of any existing devices in the marketplace that provide 3D, real-time diagnostic medical imaging, with the exception of ultrasound. Ultrasound is a real-time tomographic imaging modality. Not only does
it produce real-time tomograms of the position of reflecting surfaces (internal organs and structures), but it can also be used to produce real-time images of tissue and blood motion. However, ultrasound is a low-resolution imaging modality that does not produce an image as precise and clear as fluoroscopy. The
Company's devices will rely instead on the use of fluoroscopy, a high-resolution imaging modality, to produce "live" x-ray images of living patients in 3D.

Show me where he has failed to report millions of shares sold? Show me where he is going back now in 2010 and reporting for the first time millions of shares sold back in 2008 that he did not previously report. You can't. Because it's not happening. He is correcting reports from back then, and in some cases, actually clarifying that he sold fewer shares than were reported at that time. Please confirm the facts before you throw around allegations of wrongdoing.

Another false allegation. These amended form 4s do not reflect unreported sales, and certainly not sales of millions of shares. They are exactly what they say they are, amended reports of small amounts of shares having been sold and already reported, but with some minor issues in the reporting form. You guys throw around some of the most nasty allegations without any support in fact.

Exactly, BT. There was a shareholder meeting tentatively scheduled, at which a vote would have been taken for the authorization of new shares. That meeting was postponed. There was never any effort to increase the authorized shares without a shareholder vote, as gdsgds has falsely alleged, once again trying to tarnish Dean's reputation with false allegations of wrongdoing. Rather, a meeting was tentatively scheduled and then postponed so the Company could clean up some old filings and get a new meeting scheduled. That's where we are now.

That never happened.

The meeting is not today. Dean explained a while ago that they had to slap any old random date on the 10-K to get the filing in with the SEC, and then they would, at a later date, get a firm date, get the proxy materials out, and put out a PR with the actual date. The meeting will not be until at least 60 days after proxy materials go out. In sum, no meeting today, no meeting for at least 60 days after proxy materials go out, no expansion of "authorized" shares until after that.

There are no FDA questions, what in the world are you talking about? Dean has reported that he asked the FDA each of the last two months whether they had any questions or needed any additional information from him, and each time has been told they have everything they need and that the application is under review. Dean held a conference call all the way back in January, I believe, in which he detailed as much as possible the nature of the questions from the FDA, including exactly what they were looking for with regard to the Radiologist Review. There are no new questions, and the questions that the FDA asked prior to the April 5 submission were described to us when they were asked.

Just curious, why do you keep saying that the software guru at Imaging3 is Russian? Even if he is, who cares?

To our "chart" experts, if your theory depends so much on identifying resistances and supports, and you have previously identified .30 as a support, and .30 has now been tested at least 7 different times and held each time, then why do you project that it will suddenly break through and fall much lower? If your chart analysis allows you to identify a support, and the support has proven time and again to actual do what you predicted, and support the PPS at or above that level, then why do you undermine your analysis and predict that the support you identified will suddenly no longer support? What I see is that every time the PPS approaches .30 it bounces off of it nicely. Seems pretty reliable for a week now, why would that change?

Applicants do NOT pay the fee for each resubmission in response to an AI request. You would only have to pay again if you get a negative final determination; I.e., NSE and choose to submit a new 510(k) rather than go PMA. So in reality, the longer the FDA takes, the less value for the agency. More time and a fixed fee. They wouldn't waste their time if it was obviously flawed.

Apples and oranges, pal. Pre market approval, aka PMA, is an entirely different process to take a product to the market with the FDA's blessing than 510(k). What you are quoting is 100% inapplicable to the DViS.

Shaka, we've already covered this ground. The FDA does not review software for substantial equivalence to other software. The FDA doesn't care about code or the "how" of software algorithms. What they care about during a 510(k) application review is "intended use" and functionality. Below is what I posted before when you repeated these same questions a couple of weeks ago:

A large percentage of the 510(k) applications the FDA reviews deal with improvements to existing technology based on nothing more than changes to software to make the existing technology function faster or more efficiently. The reason these applications all get cleared in the 510(k) process, despite using brand new and totally different software, is because the FDA is not reviewing the software itself for SE. That's not the analysis. The analysis is: (1) whether the "intended use" of the new device and the intended use of the predicate are SE; i.e., intended to be used to generate diagnostic and other images for various medical services; and (2) whether functionally they generate substantially equivalent end products; i.e., are the images generated by both devices good enough to be used for those intended uses. In other words, are the devices intended to be used for substantially equivalent services and does the new device allow the medical provider to deliver the service as effectively with both devices.

There are literally thousands of devices already approved by the FDA intended to aid in diagnosis and to be used as visual aids in medical procedures. Hundreds more that do so by generating 3D diagnostic images. So there is no question that intended use can be established to be SE. So then the inquiry moves to whether the differences in software create any functionality issues, not whether the software itself is SE. So questioning whether the software is SE is not part of the equation.

It's all about intended use and functionality. Dean's software is breakthrough not because it creates a brand new medical procedure. It's breakthrough because it dramatically increases the speed of an already existing medical procedure. So long as it's at least as effective as the existing devices for those procedures, then it passes.

Software is not compared to software. Devices are compared to devices. It's very simple.

I can, I can. Here's what it can do:

Breakthrough Medical Technology

Imaging3 has developed a breakthrough medical technology (patented) that will produce 3D medical diagnostic images in real time. Imaging3 Technology has enormous potential to contribute to the improvement of healthcare. Imagine for a moment a future healthcare center equipped with Imaging3 devices. For the first time ever, healthcare workers will be able to instantly view 3D, high- resolution images of virtually any part of the human body.

Imaging3 Technology 3D images are instantly constructed using high- resolution fluoroscopy and can be used as real time references for any current or new medical procedures in which multiple frames of reference are required to perform medical procedures on or in the human body.

Multi-Function Device

A diagnostic medical imaging device built with Imaging3 Technology can perform several functions and can replace or supplement a number of existing devices, resulting in considerable cost savings for hospitals and healthcare centers. These functions include:

* Perform real time, 3D medical imaging

* Emulate a CT scanner (at a fraction of the capital cost)

* Perform standard fluoroscopy

* Cross over to other modalities such as digital radiography
__________________________________

Imaging3 Technology has extraordinary market potential in an almost unlimited number of medical applications. The ability to use an Imaging device for multiple modalities dramatically increases the return on investment.

• Trauma Center

• Orthopedic

• Pain Management

• Vascular

• Non-vascular


Imaging3 Technology - Dominion Vi Scanner - would increase the speed and accuracy of diagnosis in a trauma environment where seconds matter. Having the ability to view images of the patient in three dimensions in real time could be the difference in providing the correct diagnosis and could be the difference between life and death.

Imaging3 Technology would provide 3D images of bones and soft tissue to help diagnose and repair difficult fractures and sprains. An orthopedic surgeon could utilize the Imaging3 Technology for alignment purposes as in hip and fracture pinning, saving time without having to reposition the patient or imaging device.

Imaging3 Technology - Dominion Vi Scanner - would provide a real time 3D view of the spine to assist physicians in guiding needle placement for nerve blocks and discograms. By viewing multiple angle simultaneously a physician's accuracy and throughput is increased. Superior image quality would also provide for better diagnosis.

Imaging3 Technology - Dominion Vi Scanner - would provide a 3D view of injection dye in real time. A physician could then diagnose vascular disease more accurately and rapidly than today's conventional approaches. By viewing around denser areas of anatomy and bone, a physician would be better able to determine diagnosis in a single injection. 3D imaging in real time would greatly aid in the positioning of stents and catheters, as well as allow for the viewing of leakage.


Medical Technology Applications

Imaging3 Technology has extraordinary market potential in an almost unlimited number of medical applications. This ability to use this technology for multiple modalities dramatically increases the return on investment.


Computer Guided & Robotic Surgery

Imaging3 Technology would provide a 3D image in real time with the addition of the P.A.I.L.S., Patient Anatomy Identification & Location Software, software the Physician could now have control of the image information and relate this information to any form of guided surgical technique to the patient. This would save a great deal of time, money and equipment used to interface with existing equipment as well as equipment being developed in the future.


Cardiology

Imaging3 Technology could provide a 3D view of a heart and allow a cardiologist to record the heartbeat in real-time. The entire heart would be visible, including veins that are wrapped around the "back" side.


Computer Guided & Robotic Surgery

By adding Patient Anatomy Identification & Location Software (PAILS) to Imaging3 Technology, the Physician could then have control of the image information and relate this information to any form of guided surgical technique to the patient. This feature would save a great deal of time, money and equipment used to interface with existing equipment as well as equipment being developed in the future.


Sports Medicine

Imaging3 Technology would provide real time 3D imaging to Sports Medicine Practitioners whose patients range from Soccer Moms to Sports Celebrities. Giving these Physicians information in 3D real time increased diagnostic accuracy as well as increasing throughput and quality of patient care.


Pediatrics

Imaging3 Technology would provide a real time 3D with a dose lower than standard fluoroscopy. The benefits of being able to diagnose children quickly and with a lower dose would be very attractive to any facility.


Urology

Imaging3 Technology would provide a real time 3D image of the cervical space and associated organs, better enabling the Physicians to perform delicate diagnostic and interventional procedures.

__________________________________

TRUE 3D Real Time Medical Imaging

Imagine for a moment a near-future healthcare center equipped with Imaging3 devices. For the first time ever, healthcare workers will be able to instantly view 3D, high-resolution images of virtually any part of the human body. Imaging3 Technology 3D images are instantly constructed using high-resolution fluoroscopy and can be used as real time references for any current or new medical procedures in which multiple frames of reference are required to perform medical procedures on or in the human body.

The DViS will significantly alter the current medical imaging landscape by providing many benefits contained within one device.

True 3D Real-Time High Resolution Images
Mobile Form Factor Fits Through a Standard Room Door
No Shielded Room Required – Device Can Be Wheeled From OR To ER
Works on Standard 110v Wall Outlet Power
Emulates a 16-Slice CT Scanner at a Fraction of the Cost
Standard 2D Fluoroscopy - Still and Real-Time Imagery for Diagnostics
Multiple Pivot Points for Minimal Patient Movement
Standing Load-Bearing Imaging Capable
Price Point Well Below Existing CT Devices
Real Time Rendering Increases Facility Revenues Through Decreased Imaging Time
Image Capture at 30 Frames Per Second
Major Reduction in Exposure to Radiation
Broad Application Across Multiple Disciplines
Reduced Surgery Risk and Shorter Recovery Times
Enables New Procedures Not Possible Today
Increases Speed and Accuracy of Existing Procedures
Enables Less Invasive and More Precise Procedures


Imaging3 Technology has enormous potential to contribute to the improvement of healthcare. It is representative of the disruptive technology that is changing health care in the 21st century. Smaller, faster, less expensive tools benefit doctors, patients, and facilities, as the merging of the technology and the health care industries create efficiencies and increased value.
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Dominion VI Scanner has No Direct Competitors

At this time, the Company's management is not aware of any existing devices in the marketplace that provide 3D, real-time diagnostic medical imaging, with the exception of ultrasound. Ultrasound is a real-time tomographic imaging modality. Not only does it produce real-time tomograms of the position of reflecting surfaces (internal organs and structures), but also it can be used to produce real-time images of tissue and blood motion. However, ultrasound is a low-resolution imaging modality that does not produce an image as precise and clear as fluoroscopy. The Company's invention relies instead on the use of fluoroscopy, a high-resolution imaging modality, to produce a "live" X-ray image of a living patient in 3D.

Tig, I've started doing some chart analysis myself, and I think I have the hang of it now. Tell me if I have this correct:

If the PPS moves up, it will be higher, and if it breaks above a resistance, it will be higher than the resistance, and we will look to see if it can break through another resistance that we will identify at that time, but, if the PPS starts to fall, it will be lower, and if it goes below a support, it will be below the support, and we will have to identify other lower supports. Fortunately, there are about 20 different lines, trends, and historical numbers on the chart where the stock once sat, so there will never be a shortage of new supports and resistances.

Does that sound right?

As has been posted here numerous times, all manner of a Company's existing marketing materials, including in particular, a Company's website, are part of the materials reviewed by the FDA during the 510(k) process, and Imaging3's website is replete with references to real time 3D imaging. The website has a section on technology that lists the intended uses of the DViS. The FDA would pay particular attention to this, to see if it jives with the intended use statement submitted with the 510(k) application. Note that this page on the website used to reference mammography as an intended use, but now it does not. You want to know why? It's because Dean removed mammography from the intended use statement in the DViS 510(k) application. It's not like the device suddenly couldn't do mammography any more, it was removed from the 510(k) application to speed up the 510(k) approval process, but since it was removed from the intended use statement in the application, it had to be, and was immediately removed from the Imaging3 website and all of the other DViS marketing materials. Dean would have to do the same thing with real time 3D imaging, and he hasn't. It's all over the website, all over the building, all over their marketing materials, all over their RSNA display booth, and it's described over and over again by Imaging3 in every single one of its filings with the SEC.

This is issue is clear, if you want to know what functionality was included in the Intended Use statement of Imaging3's 510(k) application for the DViS, just look at the intended use description on the Imaging3 website. They will mirror each other.

There is no ambiguity in these situations. The FDA's guidance is crystal clear, there are only three instance in which the clock is stopped: (1) final determination (SE/NSE), which is communicated by a formal clearance (or NSE) letter; (2) an informal request for additional information followed by a formal "hold" letter; and (3) a formal written AI Request. There is no room for interpretation by the applicant or the public. The clock only stops if there is a formal written communication from the FDA stating explicitly that the clock is on Hold or stopped because of a formal AI request.

On the last conference call, this exact question in those exact words was put to Dean and he answered as clearly that he had received no written hold letter, no written AI request and no other communication from the FDA informing him the clock had stopped. Dr. Polk just posted that Dean even explicitly asked the reviewer if the clock had stopped and they said no. This is not a matter of dispute. It is resolved. That being said, it doesn't guarantee anything will happen at any given time. The clock is still ticking, the clock has passed 150 days, the clock will keep ticking until we hear. Dean is not hiding anything from anybody. It would be one thing to wonder about that in a vacuum, but when the question was put to him directly and clearly with no wiggle room, he answered it just as clearly... he had not received any written request for AI nor had he received a "Hold" letter. When this process is completed with the FDA, those communications with the FDA will be available by FOIA, and if he was lying in answer to those questions, he will be ruined. He knows that, and hence, he would not lie.

The FDA does not publicize any information about pending applications. The only devices for which you can find any information on the FDA's site or any other public sites reporting about FDA 510(k) applications are approved/cleared devices. The process is confidential until a final determination is made by the FDA.

Just curious, are you as confident that the FDA is going to ask more questions now, as you were when you predicted that the purpose of the last two MoneyTV spots and the most recent Conference Call were for Dean to announce that the FDA had already asked more questions? Because in all three of those settings Dean said that he contacted the FDA at least twice to ask them if they had any more questions, and each time was told by the FDA review team that they did not have any questions about the DViS application.

It still requires the glasses, which surgeons expressly hate. The manner in which 3D is generated, by use of the glasses, causes headaches and skews the surgeons' vision, which they simply will not accept. This technology has been around for a while and has failed every step of the way.

Furthermore, the Viking is only for little penny ante minimally invasive procedures, not the big boy stuff that the DViS will be used for. It is no competition.

I'm not. Someone suggested that Viking had "beaten the DViS" to market and would reflect a competitive challenge to the DViS. The fact is, the Viking is no competition to DViS at all. I'm glad we have found something about which we agree.

Imaging3 vs. Viking

Imaging3's DViS, when cleared by the FDA, will be competing in the medical imaging market against other manufacturers of 3D imaging devices. One of those competitors is Viking, who recently got an add-on / upgrade of its 3D device cleared by the FDA in the same 510(k) process that Imaging3 is going through right now. What is happening with Viking, both in terms of the FDA and in the medical imaging market, is very much relevant to Imaging3, hence, Likeahawk's inquiry about how Viking will affect Imaging3. My response to that inquiry was deleted, I guess because the connection between Viking and Imaging3 was not expressed. Hopefully this paragraph resolves that issue. The following is the original post that was deleted:

I didn't need to do any new diligence about Viking's 3D device as it relates to Imaging3's DViS device. The Viking device (and its baseline technology) has been around and it's no competition at all. Specifically, the Viking device requires the physician to wear 3D glasses (like you're watching the movie Avatar), and this has already proven to be a huge failure in the medical industry. Surgeons hate putting on those glasses, they have had big problems with headaches and adjusting eyes between the two views. It’s like making a right handed quarterback play left handed; it doesn’t feel natural and they won’t do it. Viking is not the first to try 3D medical imaging with 3D glasses, and they have all been abject failures. The glasses create 3D by separating colors and showing different parts of the image to each eye and requiring the brain to put it back together again to look like 3D. If you’ve ever worn the movie 3D glasses you have the general idea.

On the other side of the coin is Imaging3's DViS, which utilizes perspective to show 3D. You don't need 3D glasses, you just look at the images on the screen or print off hard copies just like traditional CT and Fluoro devices... just faster. It is widely accepted that this is a far superior way for medical professionals.

Note that Viking’s recent 510(k) clearance was just an upgrade/add on. The actual original Viking device was cleared more than a year ago, so the device has been on the market for a while, and it has not been a success. Ask any radiologists or surgeons you know and they will laugh in your face if you suggest that they put on 3D glasses to read a scan or perform a procedure. The Viking is a gimmick and is no competition at all for the DViS.

If you get an NSE determination, you cannot resubmit that application. NSE is very different from AI. When you get an AI request, you resubmit the same application with the additional information requested by the FDA. You cannot do that with an NSE.

If you get an NSE determination, you can appeal the decision, go the PMA route or start over with a new and different application.

You can add as many exclamation points as you want, Kimble, but that won't make your statement any less wrong.

SE = Accepted.
NSE = Rejected.
AI = More akin to conditional acceptance than rejection. I.e., if you can provide us with x, y & z, then we will Accept it.

Rejection is clear cut and it exists. It's called Not Substantially Equivalent (NSE), and Imaging3 has never gotten an NSE notification.