UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of January 2022

 

Commission File Number: 001-39461

 

NANO-X IMAGING LTD

 

Communications Center

Neve Ilan, Israel 9085000

(Address of principal executive office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F ☒ Form 40-F ☐

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

 

Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐

 

Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.

 

 

NANO-X IMAGING LTD (the "Company”) announces that on January 12, 2022 it has submitted with the Food and Drug Administration ("FDA") a Q-submission for the second version of the Company’s multi-source Nanox.ARC 3-D tomosynthesis imaging system, that produces images of human anatomies. This  version of the Nanox.ARC is an improved and enhanced version that was designed, among other things, to address certain deficiencies raised by FDA during their review of the earlier submission from June 2021, which was withdrawn to enable the Q-submission.

 

Nanox received FDA clearance of its single source Nanox Cart X-Ray System in April 2021.

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

	NANO-X IMAGING LTD
	By:	/s/ Ran Daniel
	Name:	Ran Daniel
	Title:	Chief Financial Officer

 

Date: January 18, 2022