Benzinga | Aug 19, 2021 10:33AM EDT

Nano X Imaging Earlier 8-K Showed Co. Received Request For Added Info From FDA Related To Co.'s Last 510(k) Submission Of Its Nanox.ARC; Co.'s Response Is Due Within 180 Days From Date Of Request

On August 12, 2021, NANO-X IMAGING LTD (the "Company") received a request for additional information from the U.S. Food and Drug Administration (the "FDA") concerning the Company's last 510(k) submission of its multi-source device, Nanox.ARC. The submission file is placed on hold pending a complete response to the FDA's list of deficiencies. The Company's response is due within 180 days from the date of the request for additional information.



The Company plans to respond by the due date which is 180 days from the date of the request for additional information. The Company expects to continue to optimize and develop further features of Nanox.ARC and is considering submitting an additional 510(k) application for the next version of multi-source Nanox.ARC during the fourth quarter of 2021, which will benefit from the FDA's feedback on the first version of the multi-source Nanox.ARC.