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Imaging3 Engages Med-Device Consulting, Inc. to Assist on 510(k) Application with the FDA
Imaging3 Engages Med-Device Consulting, Inc. to Assist on 510(k) Application with the FDA.
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[{"type":"text","content":"\n\n BURBANK, Calif., June 12, 2017 (GLOBE NEWSWIRE) -- Imaging3, Inc. (OTCQB:IGNG) announced today that on June 5, 2017 the Company hired Med-Device Consulting, Inc. to facilitate the 510(k) application to the FDA in order to obtain approval for its Dominion VI imaging device with patented SmartScan™ 3D technology.\n Med-Device Consulting provides a wide range of personalized regulatory and medical quality-assurance consulting services. They have helped numerous medical device companies worldwide with 510(k) submissions, with quality-assurance and regulatory systems, with CE-mark preparation, and with ISO certification.  Med-Device represents client organizations throughout the nuanced process of engaging with the FDA, coordinates with the FDA on behalf of sponsors at meetings and via regular correspondence with the FDA during the entire lifecycle of a product, and provides support in all aspects of marketing applications, including review and editing, safety descriptions, and statistical analysis plans. They are replacing Biologics as the company’s primary regulatory liaison. President Dane Medley stated: “As part of our regulatory success strategy, we have been extremely discriminating in our selection of vendors. The engagement of Med-Device Consulting is one such example; and the hiring of CriTech Research to validate the massive software component of our Dominion VI imaging device was another. With professionals like that providing guidance each step of the way, we are optimistic we will have a successful interaction with the FDA.” Special consultant Scott Pancoast added, “Imaging3 continues to make progress, both financially and operationally.  The addition of Med-Device to the team positions the company well for eventual FDA approval and commercial success.” About Med-Device Consulting, Inc.The mission of Med-Device Consulting, Inc. is to assist companies in meeting their strategic objectives by providing highly specialized expertise and assistance on a project, temporary or on-going basis. Find out more by visiting: http://www.m-dci.us About Imaging3 Inc.Imaging3, Inc., founded in 1993, has developed a patented medical imaging technology, called SmartScan™, that will produce 3D x-ray images, virtually in real time. The SmartScan technology will allow healthcare pr...