NNOX - Nanox submits 510(k) application for first version of Nanox.ARC 3-D in U.S.

Nano-X Imaging (NNOX) has submitted a 510(k) premarket notification application to the FDA for the first version of its multi-source Nanox.ARC 3-D digital tomosynthesis system. 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. Nanox received FDA clearance of its single source Nanox Cart X-Ray System in April 2021.

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Nanox submits 510(k) application for first version of Nanox.ARC 3-D in U.S.