FDA Device Info: Records Concerning NANO-X IMAGING

Records concerning submitter NANO-X IMAGING LTD, including, but not limited to, any records related to communication, for example, submission letters, hold letters, acknowledgement letters, interactive review emails or transcripts, requests, recommendations, withdrawals, replies, major deficiency letters, answers to regulatory questions, exchanges under the "Ask the FDA Expert," decision letters, and so on, and/or supporting documents related to a 510K submission to the Center for Devices and Radiological Health or under the Third Parties (also known as Accredited Persons or Review Organizations or 3P510k) Program, or information submitted to obtain recognition or rerecognition from FDA. [REQ YEAR: 2020]