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News Release
Imaging3 Scheduled to File with the FDA
Important Milestone Scheduled to Start by Mid-June 2007
Imaging3™, Inc. (OTCBB:IMGG), developer of a breakthrough medical imaging device that produces 3D medical diagnostic images of virtually any part of the human body in real-time, announced today that it expects to file a 510(k) submission with the FDA by June 15th for the DominionTM 3D real-time imaging device.
The FDA 510(k) submission is a device equivalent submission comparing the Functionality, Intended Use and Energy Transmission with similar devices currently on the market. The process can take 6 months or more depending upon the complexity of the product and quality of the application. "We’re extremely excited to be ready to file our 510(k) submission with the FDA. We hope to obtain FDA approval by year-end, but understand the process could continue into 2008. We have generated enough data through our initial stages of Beta Testing that we are now confident we can proceed with the FDA filing," stated Dean Janes, Chairman and CEO.
Mr. Janes also pointed out that "off-the-shelf" components are used, such as the X-Ray source and Image Receptor, in the Dominion, and stated further, "While it is no guarantee, the fact that we are using 'off-the shelf' components known to the FDA, it should help to speed the approval process along." Mr. Janes concluded his remarks by pointing out that this will be the fourth Fluoroscopy based device that he has guided through the FDA 510(k) approval process.
About Imaging3, Inc.
Imaging3, Inc., founded in 1993, is a leading provider of advanced technology medical imaging devices. The Company has developed a breakthrough technology (patented) that will produce 3D medical diagnostic images in real-time. Because these 3D images are instantly constructed in real-time, they can be used 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.
Imaging3 Technology can to contribute to the improvement of healthcare. By providing this higher quality and quantity of information, the physician or clinician will be able to perform any procedure with a higher level of accuracy while decreasing the time spent performing the procedure. By increasing throughput while increasing diagnostic and clinical accuracy, Imaging3 Technology becomes an attractive new technology that will provide healthcare centers with a high return on investment.
For more information about Imaging3, Inc., please visit the Company's Web site
www.Imaging3.com
Safe Harbor Statement
Matters discussed in this press release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. When used in this press release, the words "anticipate," "believe," "estimate," "may," "intend," "expect" and similar expressions identify such forward-looking statements. Actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements contained herein. These forward-looking statements are based largely on the expectations of the Company and are subject to a number of risks and uncertainties. These include, but are not limited to, risks and uncertainties associated with: the impact of economic, competitive and other factors affecting the Company and its operations, markets, product, and distributor performance, the impact on the national and local economies resulting from terrorist actions, and U.S. actions subsequently; and other factors detailed in reports filed by the Company.
Contact:
Imaging3, Inc.
Media Relations
(818) 260-0930
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