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Your statement is false. The FDA can clear any item they wish, just because they didnt send you a copy, does not mean it was not cleared.
ALL: Here is a Letter from the FDA In response to my questions. This is why Dean cannot show the Dominion to shareholders. Read line 2 in the response very carefully.Only the FDA can clear for marketing! The emails have been posted in their entirety with the exception of my personal information being removed.
From: Eva.Ellsworth@fda.hhs.gov
To: xxxxxxxxxxxxxxx CC: DSMA@CDRH.FDA.GOV
Date: Fri, 25 Feb 2011 16:29:49 -0500
Subject: 02-589 eje CDRA Devices
Dear XXXXXXXXXXXX,
Only items currently undergoing 510(k) review can be demonstrated or marketed. No promotion or advertising activities can be performed before the device has been cleared for marketing. Demonstrations of the device on television, video, the internet, or any other medium are considered to be marketing. The same is true of still print displays and other information about the device that is made available to the public.
You can have a display unit to show the shareholders. The display unit must be clearly marked with “For display purposes only” and “Not for human use.”
After your company submits a new 510(k) application for the device, you can display samples of the product at trade shows if the following conditions are met:
Samples/display devices for trade shows:
• The labeling on the device indicates that the device is for display purposes only and is not to be used on human subjects.
• The import paperwork should clearly indicate that the item is not for commercial distribution in the USA but for display purposes only, and
• The import paperwork should also indicate when the item will be sent back to the foreign company afterwards or otherwise disposed of.
Additionally, you can not market the device at trade shows before it has received 510(k) clearance from the FDA. Marketing includes distributing brochures, taking “pre-orders,” getting contact information from potential customers, etc.
If you need further assistance, please don’t hesitate to call DSMICA at 1-800-638-2041 or email us at DSMICA@CDRH.FDA.GOV. You may also call me at 301-796-5855. You can email me at Eva.Ellsworth@fda.hhs.gov.
Cordially,
Eva Ellsworth
Eva Ellsworth
Consumer Safety Officer
Division of Small Manufacturers, International and Consumer Assistance
Center for Devices and Radiological Health
Office of Communication, Education, and Radiation Programs, US FDA
Phone: 301-796-5855
Fax: 301-847-8149
This response represents to the best of my judgment how the device should be regulated, solely based upon a review of the information you have provided. This response is not a classification decision for your device and does not constitute FDA clearance or approval for commercial distribution. Unless exempt from premarket notification submission (510(k)) requirements, the official classification for your device will appear on the final decision letter from any premarket review. All device types classified as exempt from the 510(k) requirements are subject to the limitations of exemptions. Limitations of device exemptions are found in the device classification chapters in 21 CFR xxx.9, where xxx refers to Parts 862-892 (e.g., 862.9, 864.9, etc.). Please be aware, if I have indicated that I believe your device falls within a device category classified as exempt from premarket review requirements, that it is your responsibility to ensure that you meet the exemption criteria and your device does not exceed the limitations of exemption. If your device exceeds the limitations of exemption, you must submit a 510(k) and receive a letter from FDA stating that your device may be commercially distributed in the U.S. prior to marketing your device.
This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
You can now follow CDRH on Twitter at http://twitter.com/FDAcdrhIndustry
________________________________________
From: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
Sent: Thursday, February 24, 2011 12:43 PM
To: CDRH Small Manu. Assistance
Subject: CDRA Devices
Dear Sir
My questions concerns a radiological emitting devices. If a manufacture has produced a device but has not received SE, nor is currently enrolled in an active 510K or PMA application. Can the manufacture show the device being operated and producing images to the shareholders? Can they use the internet, TV, or video to show the device in real time use? Is showing the device in operation to the public considered marketing?
If there are regulations in place by the FDA to prevent this for what ever reason can you provide those documents?
The statement below was in the NSE letter to the company.
You may not Market this device until you provided adequaic information described above and required by 21 CFR 807.67 (J) and you have received a letter from the FDA allowing you to do so. If you market the device without conforming to these requirements you will be in violation of the Act.
Any help you can provide will be greatly appreciated.
Thank you
XXXXXXXXXXXXXXX
xxx-xxx-xxxx
AT
I never mentioned phantom in my post. You do realize we are speaking of 3 very different objects here?
Live Human - self explanatory
Cadaver - Dead body
Phantom - Manmade object to simulate a human body or body part.
Read what you want. Each person can make their own interpitation.
KF
Mugs
Have you even looked at the Sticky Box. It was posted 30 minutes ago!
AT Cadavers tend to be a little STIFF, but I think the FDA would still consider them soft tissue. After last year’s public uprising over the Radiological Devices causing harm to patients do you really think they want to take chances now with Living humans?
Some here are just reading what they want to see!
KF
It looks like IMGG closed up today. I hope everyone has a Great Weekend!
KF
madtig6
How did todays action effect the chart outlook? TIA
All: Here is a condensed version of the NSE I compiled this morning. These are the items that the NSE is requesting from Imaging3 for the Dominion to receive SE.
1. CT emulation images, and a detailed description of the reconstruction algorithms used to create the 3D constructs
2. Sample Images from Predicate Device including soft tissue. Data sets associated with the sample image loops in the submission.
3. Clinical Study: Provide Solid-State X-ray Imager Data
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073780.htm#17
4. Detailed description of cone beam reconstruction.
5. Provide a more detailed description of your reconstruction technique.
6. Software Documentation: sufficient to determine the safety and effectiveness of the device.
7. Device Hazard Analysis.
8. Software Requirements Specifications(SRS)
9. Software Design Specification (SDS)
10. Traceability Analysis
11. Development Environment Analysis
12. Programmable Electrical Medical Systems Verification and Validation Documentation
13. Revision Level History: history of software revisions generated during the course of product development.
14. Off-the-Shelf Software: Please provide basic documentation for off-the-shelf software used in your device.
15. Vibration analysis.
16. Overheating analysis.
17. Lateral Patient Access analysis.
18. User Sync Detector Mode: data evidence from supplier and testing.
19. User's Manual: Deficiency: description of all post-processing features of this device.
20. Over-the-Counter Use: identify a predicate device for over the counter use. Demonstrate that your device meets the requirements of 21 CFR § 801 Subpart B (Labeling Requirements for Over-the-Counter Devices).
21. Electronic Copy: provided in accordance with the guidelines.
Thanks for the link P4P
Mugs &....the SEC does not spin their wheels when they suspend and formally investigate a public company and involved persons. I have found no evidence of your claims at the SEC sites listed below. If creditable evidence is found by the SEC they act swiftly.
.
SEC Litigations:
http://www.sec.gov/litigation/litreleases.shtml
SEC Administrative Proceedings:
http://www.sec.gov/litigation/admin.shtml
SEC Suspensions:
http://www.sec.gov/litigation/suspensions.shtml
Homer Simpson
I doubt any attorney would reveal that information!
Bans and restrictions continue.
IH Admin [Dan] Share Thursday, February 10, 2011 1:47:00 PM
Re: None Post # of 37678
Folks please stay on topic. The only topic to be discussed here is IMGG.
There have been too many deletions here recently. Please take time to read these rules so that you will understand why posts have been deleted:
http://ihwiki.advfn.com/index.php?title=Handbook#Deletion_of_Posts
Any time you post about Users or reference groups of Posters (bashers, pumpers, cheerleaders, naysayers, Mods, etc.) in your post, this makes your post subject to removal as off-topic and/or personal attack. Posts about deletions are also Off Topic.
Your messages need to focus on the company and the stock and should not contain comments about people who post on the board. Other posters are never the topic of the board.
To those who received restricted posting here for their TOU violations. In order to have that released you need to post for two weeks without violating the rules, then ask for Admin to review.
If you have any questions send me a PM.
NO public replies please.
Respectfully Mr. Sano
That’s your take on the subject. I read what the FDA stated much different. Each person will have their own intrepitation. It’s obvious that neither of us work for the FDA, so I agree to disagree.
KF
It's now clear why Dean Janes can’t show the Dominion in action. He would be in violation of the Act per the FDA. Read page 8-20.
http://viewer.zoho.com/docs/d0dTh
Excerpt:
You may not Market this device until you provided adequaic information described above and required by 21 CFR 807.67 (J) and you have received a letter from the FDA allowing you to do so. If you market the device without conforming to these requirements you will be in violation of the Act.
KF
IH Admin [Dan] Share Thursday, February 10, 2011 1:47:00 PM
Re: None Post # of 38006
Folks please stay on topic. The only topic to be discussed here is IMGG.
There have been too many deletions here recently. Please take time to read these rules so that you will understand why posts have been deleted:
http://ihwiki.advfn.com/index.php?title=Handbook#Deletion_of_Posts
Any time you post about Users or reference groups of Posters (bashers, pumpers, cheerleaders, naysayers, Mods, etc.) in your post, this makes your post subject to removal as off-topic and/or personal attack. Posts about deletions are also Off Topic.
Your messages need to focus on the company and the stock and should not contain comments about people who post on the board. Other posters are never the topic of the board.
To those who received restricted posting here for their TOU violations. In order to have that released you need to post for two weeks without violating the rules, then ask for Admin to review.
If you have any questions send me a PM.
NO public replies please.
Thank you for the article Frank39
bogdan1 Thank you
I now fully understand your short, precise answers with your upcoming court case that you told us about here at the board, in your previous post here.
KF
patientinvestor'
They speak for themself!
kimble1 Share Saturday, February 19, 2011 6:15:55 PM
Re: A deleted message Post # of 37875
when i first bought my shares ( a couple million through PPM) and another million on open market there was about 100 of us who controlled 100-125 million shares
Dean went on MONEY TV and repeatedly pounded the FDA APPROVAL IS IMMINENT and "IT IS NOT IF BUT WHEN"....
as investors (get rich quick folks) came running PPM shares where GLADLY unloaded to the new sheep
you say 14000 investors strong....sure that is one way to look at it
how about 14000 underwater shareholders hoping for a miracle
kimble
Oh, we all understood that statement? I was referring to your specific statements you made in this post below. Not a general cover all statement. If you choose not to respond to specifics, OK.
bogdan1 Share Wednesday, February 16, 2011 6:43:10 PM
Re: capnkirk52 post# 37566 Post # of 37856
You cannot find the facebook page because it was removed by Facebook.
I suppose that some roving Facebook team monitoring compliance with Facebook policies, on its own, decided that it violated some posting policy.
I am appealing. We shall see.
Please explain the details on your last post? You made statements of fact? Most here don’t understand why you stopped posting here so abruptly? Help Us.
bogdan1
Has there been any change since you made this post?
bogdan1 Share Wednesday, February 16, 2011 6:43:10 PM
Re: capnkirk52 post# 37566 Post # of 37856
You cannot find the facebook page because it was removed by Facebook.
I suppose that some roving Facebook team monitoring compliance with Facebook policies, on its own, decided that it violated some posting policy.
I am appealing. We shall see.
I wonder if FB saw the conection and Deleted both bogdan1 and Deans page? Has anyone considered this?
hubris heyday'
Thank you for your post
I have read the latest AI letter and listened to Dean CC call at that time. It’s clear to me that he spoke the entire truth in that call. He stated he removed the mammography and heart functions from the label. Some here, still don’t understand a 510K or that a label and intended use as far as FDA terms are one of the same.
KF
Mugs I commend you on making that determination in less than 10 minutes on 64474 posts.
Mug
For your information the SEC acts more quickly that you perceive. I moderate another board. The SEC stepped in within days upon valid complaints. The company stock was halted in trading within 7 days and is now on the Grey sheets? Please don’t underestimate the SEC. They act swiftly on accurate information.
SMF
Wow, you must live near Burbank to be counting cars in the parking lot. Did they work today? What does Dean drive? I would think a from what I read on the board It must be a Mazaradi.
Mr Sano I welcome your input.
KF
Good point Lambster
Quote
"You can't tell me that Dean and his partners had no idea at all that the FDA letters could be attained just by requesting them and posting a modest fee?"
I think your speaking of the 3 institutional investors? There is no doubt in my mind that the institutions read the AI letters prior to signing the 1 million doll check. These are not retail investors but professionals. I think all but a few can agree on this fact.
I also want to address a topic that has been brought up several times already. The SEC filing of the deal with the institutional investors and the 20K outlined in the deal. I hope all will take a moment to realize there are 5 parties involved in this deal. Any one of the parties could have a problem or speed bumps to cross other than Imaging 3. We have Imaging 3, the 3 institutional investors and the SEC. Some tend to damn Imaging 3 prior to the facts being revealed. This seems to be the trend at the board lately.
As far as Deans FB page? We have many posters here that have been screaming about this. Now Dean deletes all, and they are still screaming? I seriously doubt the SEC had anything to do with this. I think Dean is listing to MWE advice at this point.
KF
Mr. Sano
I dont disagree with your statemnet. What do you consider proper chanels? Marketwire?
IH Admin [Dan] Share Thursday, February 10, 2011 1:47:00 PM
Re: None Post # of 37818
Folks please stay on topic. The only topic to be discussed here is IMGG.
There have been too many deletions here recently. Please take time to read these rules so that you will understand why posts have been deleted:
http://ihwiki.advfn.com/index.php?title=Handbook#Deletion_of_Posts
Any time you post about Users or reference groups of Posters (bashers, pumpers, cheerleaders, naysayers, Mods, etc.) in your post, this makes your post subject to removal as off-topic and/or personal attack. Posts about deletions are also Off Topic.
Your messages need to focus on the company and the stock and should not contain comments about people who post on the board. Other posters are never the topic of the board.
To those who received restricted posting here for their TOU violations. In order to have that released you need to post for two weeks without violating the rules, then ask for Admin to review.
If you have any questions send me a PM.
NO public replies please.
Thank you prussian4profit
For cleaning up the Show Intro box. The letter from the FDA to Dean Janes is listed just under the chart for IMGG in the intro box.
Kingfisher
We continue to have many off topic and TOS post on this board. Ihub admin continues to place members on limited post and the BAN list for the violators. Please take the time to read the link in the post from Admin Dan below. I have posted the recent letter from the FDA to Dean Janes in the intro. I hope all enjoy the Holliday weekend and remember the Stock Markets are closed on Monday.
IH Admin [Dan] Share Thursday, February 10, 2011 1:47:00 PM
Re: None Post # of 37678 Folks please stay on topic. The only topic to be discussed here is IMGG.
There have been too many deletions here recently. Please take time to read these rules so that you will understand why posts have been deleted:
http://ihwiki.advfn.com/index.php?title=Handbook#Deletion_of_Posts
Any time you post about Users or reference groups of Posters (bashers, pumpers, cheerleaders, naysayers, Mods, etc.) in your post, this makes your post subject to removal as off-topic and/or personal attack. Posts about deletions are also Off Topic.
Your messages need to focus on the company and the stock and should not contain comments about people who post on the board. Other posters are never the topic of the board.
To those who received restricted posting here for their TOU violations. In order to have that released you need to post for two weeks without violating the rules, then ask for Admin to review.
If you have any questions send me a PM.
NO public replies please.
onTarget This might be a place to start.
http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
IH Admin [Dan] Share Thursday, February 10, 2011 1:47:00 PM
Re: None Post # of 37678
Folks please stay on topic. The only topic to be discussed here is IMGG.
There have been too many deletions here recently. Please take time to read these rules so that you will understand why posts have been deleted:
http://ihwiki.advfn.com/index.php?title=Handbook#Deletion_of_Posts
Any time you post about Users or reference groups of Posters (bashers, pumpers, cheerleaders, naysayers, Mods, etc.) in your post, this makes your post subject to removal as off-topic and/or personal attack. Posts about deletions are also Off Topic.
Your messages need to focus on the company and the stock and should not contain comments about people who post on the board. Other posters are never the topic of the board.
To those who received restricted posting here for their TOU violations. In order to have that released you need to post for two weeks without violating the rules, then ask for Admin to review.
If you have any questions send me a PM.
NO public replies please.
The Stock Markets will be closed on Monday.
This mornings trading looks like nothing more than a Fire Drill.
Additionally, the researchers discovered, 12% of the recalled devices that were approved under the 510(k) process were originally marketed for "risky or life-sustaining Class III (defined as implantable or life-sustaining) indications, which are required by law to undergo a full PMA regulatory review."
These 510(k) approved devices that were recalled "were used by tens of millions of patients, exposing them to potential harm and adding substantial costs to medical care," the authors wrote.
For example, the average cost for the FDA to review a 510(k) submission "was estimated at $18,200, while a PMA submission cost the agency $870,000 to review," they wrote.
Of these recalls, the largest group were for cardiovascular use and 35 – involving 31 separate devices – and most were automated external defibrillators (AEDs) approved for resuscitation of patients in cardiac arrest. About one in five of the one million AEDs in circulation have been recalled, "and hundreds of people died due to AED malfunction," the researchers wrote. Of these 35, 23 were cleared through the 510(k) process.
The second largest high-risk recall category involved 27 general hospital devices, such as insulin pumps, intravenous infusion devices and patient lifts. Of these, 20 (74%) were cleared through the 510(k) process.
The third largest high-risk recall category involved devices used in anesthesia, including mechanical ventilators. All were cleared by the 510(k) process or were exempt.
Hello Mugs
I admit I'm human. I must have missed this in my DD. Can you please provide me with written of verbal confirmation on your quote below?
I use the word rejected in regards to the failed 510k submission because I heard a MWE attorney use it when he was talking about the decision
KF
Boxer
I can only refer you to this post:
http://investorshub.advfn.com/boards/manage_msg.asp?message_id=59866244
If you have any evidance of current Federal violations or SEC violations suites, or any FOIA information you have obtained, please provide your evidence.
Mugs
I continue my DD, there is no hope involved with my investment.
It’s the same as my entry point High Risk/High Gain.
In your last post can you show me where REGECTED was actually stated? You make claims of FOIA. Can you provide your evidence of your DD where you received anything via FOIA? Or is this hear say?
Here is some DD on my part as FOIA goes, and about all I'm willing to provide at this time.
http://seekingalpha.com/article/251267-warning-biotech-investors-fda-advisory-panels-no-means-no-yes-means-maybe
This is a excerpt from the above link but it leads me to believe that the FOIA claimed, may be in violation of the law? I highlighted 2 key words. This was a response to a drug company and a CRL not a NSE. Are they not one in the same with the exception of a Drug vs Device within the FDA?. Please share your DD and provide your facts to back up your statements.
The FDA is transparent with regard to drug approvals and withdrawals, but the contents of CRLs are considered confidential because they represent part of an ongoing dialog between the agency and drug sponsor. While many companies disclose whether or not a CRL contains a request for new clinical studies, translating into an investment of more capital and time, ambiguous phrases describing the contents of a CRL often leave investors in the dark with regard to handicapping the sponsor’s ability to address the issues in a timely and efficient manner – if at all. Such secrecy has come under fire by members of the media, as evidenced by an October 2010 Forbes article titled
KF
Emperor JoeBari
What I read here from the Con posters of IMGG are the same comments on any company that the share price has gone down. It’s obvious to me there are many Shareholders in the RED at this time, and this is place for them to vent their frustration and dislike for the CEO they blame for their position at this time. This message board is a place for people to reach out to be heard by anyone that will listen.
IMGG has dissatisfied and disgruntled few shareholders. IMGG has 14,000 shareholders. This board has 255 people that follow it. That number is a pittance in comparison of the total shareholder group.
From what I have seen in the share price and trading .15 has held for a very long time now. It appears to me from what the charts are saying is that the majority of shareholders are willing to wait for now. This imo, is due to Dean Jane’s hiring competent people that have an extensive background with the FDA. I’m sure no guarantees have been made, but from the resumes I have found in my DD, I’m willing to wait and see what the FDA outcome will be. I have never felt this was a scam. The hiring of the consultants and MWE has just affirmed this. This is not the first nor last company MWE will represent.
GLTA
KF