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Imaging3 Engages Intertek to Assist with Hazard Analytic Requirements Relating to the 510(k) Application with the FDA


Imaging3, Inc. [OTCQB:IGNG] announced today that on June 14, 2017 the Company hired Intertek, Inc. to remediate the hazard analytics and manage the FDA guidance protocols of submission requirements outlined by the FDA, in order to obtain approval for its Dominion VI imaging device with patented SmartScan™ 3D technology.

Intertek has an established track record of over 130 years in business and is an industry leader with more than 42,000 employees in 1,000 locations in over 100 countries. They deliver Quality Assurance expertise with industry-winning processes and a customer-centric culture. They ensure that products meet quality, health, environmental, safety, and social accountability standards for virtually any market around the world, and they hold extensive global accreditations, recognitions, and agreements.

President Dane Medley stated: “We continue to have extraordinarily high standards in our selection of vendors. The engagement of Intertek is yet another example, along with Med-Device Consulting, who is assisting with our 510(k) applications generally, and CriTech Research, who is assisting with the immense software component of our Dominion VI imaging device. This game-plan of working only with the best maximizes our chances of a successful outcome with the FDA.”

Special consultant Scott Pancoast added, “It is heartening to witness the transformation of Imaging3. The team has been successful in stabilizing its financials and now it is making great progress in stabilizing its operations. Choosing the right vendors is key, especially when working with complex regulatory matters.”

About Intertek, Inc. The mission of Intertek, Inc. is to assist companies in meeting their strategic objectives by providing highly specialized expertise and assistance with a project, either on a temporary or on-going basis. Find out more by visiting: http://www.m-dci.us THIS IS MED DEVICE’s WEBSITE! 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 professionals to perform diagnostic and therapeutic procedures more quickly and accurately, resulting in higher throughput for the clinicians and fewer safety risks for the patient. In addition, Imaging3’s technology exposes patients to significantly less harmful radiation than current imaging technologies such as CT scans, which the company believes will allow scans to be used in more pediatric applications than are currently prescribed. The technology also allows for greater portability, easier installation, and a significantly reduced cost burden for the healthcare system overall. Imaging3 is planning to submit a 510K application to the FDA during 2017 in order to gain approval to commercialize the SmartScan technology.

Visit the company’s website at http://www.imaging3.com for detailed information about the Company’s technology