About Imaging3 Inc.
Imaging3, Inc., founded in 1993, has developed a patented medical imaging technology, called the Dominion SmartScan™, that produces 3D x-ray images, effectively in real time. The SmartScan technology has the potential to allow healthcare professionals to perform diagnostic and therapeutic procedures more quickly and accurately, which may result in higher throughput for the clinicians and fewer safety risks for patients. Imaging3’s technology exposes patients to less harmful radiation than current equivalent imaging technologies such as CT scans. The company believes this will allow scans to be used in many settings where scanning is currently limited by concerns about radiation exposure. The technology also notably allows for reasonably convenient portability, easier installation and use-readiness, and a significantly reduced cost burden suitable for novel settings and for healthcare systems across varied global settings. Imaging3 plans to submit a 510(k) application to FDA during 2018 to gain marketing authorization for initial applications for the SmartScan technology. The company's website has (dated) sample images from a prototype model posted for viewing on its website. There are several cone beam CT (CBCT) on th market for dental, orthopedic, and ENT applications. Some of them were approved via the FDA 510k process. For a synopsis of Cone-Beam CT (including regulatory issues) refer to: Cone-Beam CT David Spelic, PhD Division of Radiological Health Office of In Vitro Diagnostics & Radiological Health Center for Devices and Radiological Health U.S. Food and Drug Administration David.Spelic@fda.hhs.gov Technical Electronic Product Radiation Safety Standards Committee Meeting, October 25-26, 2016 https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Radiation-EmittingProducts/TechnicalElectronicProductRadiationSafetyStandardsCommittee/UCM526270.pdf There was past legal action against the former CEO of this company several years ago. The current management of the company has publically denied any involvement with the former CEO. The SEC action was resolved prior to reorganization. https://finance.yahoo.com/news/imaging3-inc-announces-resolution-sec-230000497.html