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Nanox Announces FDA 510(k) Submission for First Version of Multi-Source Nanox.ARC
510(K) Class II FDA submission seeks clearance of the first version of company’s multi-source 3-D digital tomosynthesis system as the next step in its U.S.
About this update from Nano-x Imaging Ltd
[{"type":"text","content":"510(K) Class II FDA submission seeks clearance of the first version of company’s multi-source 3-D digital tomosynthesis system as the next step in its U.S. regulatory process\nNEVE ILAN, Israel, June 17, 2021 (GLOBE NEWSWIRE) -- NANOX IMAGING LTD (NASDAQ: NNOX) (“Nanox” or the “Company”), an innovative medical imaging technology company, announced today that the Company has submitted a 510(k) premarket notification application to the U.S. Food and Drug Administration (FDA) for the first version of its multi-source Nanox.ARC 3-D digital tomosynthesis system. “The 510(k) submission for the first version of our multi-source Nanox.ARC is an important achievement,” stated Ran Poliakine, Chairman and Chief Executive Officer of Nanox. “There exists a significant unmet medical need globally for a more accessible and cost-effective medical imaging solution. If cleared by the FDA, we believe our Nanox.ARC 3-D digital tomosynthesis can address this need.” The first version of the multi-source Nanox.ARC will be followed by future Nanox.ARC versions. Nanox.ARC is a 3-D tomosynthesis imaging system that produces scans of a human body part. The system is being designed for easy setup and operation with multiple alternately-switched X-ray tubes arranged around the patient. “We are excited to take this next step in our regulatory process as we move toward future versions of the multi-source Nanox.ARC, which will fulfill current and future contracts with service providers and collaboration agreements and allow us to achieve our global vision,” added Mr. Poliakine. Nanox received FDA clearance of its single source Nanox Cart X-Ray System in April 2021. About Nanox: Nanox, founded by the serial entrepreneur Ran Poliakine, is an Israeli corporation that is developing a commercial-grade digital X-ray source designed to be used in real-world medical imaging applications. Nanox believes that its novel technology could significantly reduce the costs of medical imaging systems and plans to seek collaborations with world-leading healthcare organizations and companies to provide affordable, early detection imaging service for all. For more information, please visit www.nanox.vision. Forward-Looking Statements: This press release may contain forward-looking statements that are subject to risks and uncertainties. All statements that are not historical facts ...