<SEC-DOCUMENT>0001140361-21-002785.txt : 20210201
<SEC-HEADER>0001140361-21-002785.hdr.sgml : 20210201
<ACCEPTANCE-DATETIME>20210201060903
ACCESSION NUMBER:		0001140361-21-002785
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20210201
FILED AS OF DATE:		20210201
DATE AS OF CHANGE:		20210201

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Nano-X Imaging Ltd.
		CENTRAL INDEX KEY:			0001795251
		STANDARD INDUSTRIAL CLASSIFICATION:	X-RAY APPARATUS & TUBES & RELATED IRRADIATION APPARATUS [3844]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			L3
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-39461
		FILM NUMBER:		21574174

	BUSINESS ADDRESS:	
		STREET 1:		COMMUNICATIONS CENTER
		CITY:			NEVE ILAN
		STATE:			L3
		ZIP:			9085000
		BUSINESS PHONE:		972 02 995 0506

	MAIL ADDRESS:	
		STREET 1:		COMMUNICATIONS CENTER
		CITY:			NEVE ILAN
		STATE:			L3
		ZIP:			9085000
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>nt10018955x2_6k.htm
<DESCRIPTION>6-K
<TEXT>
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      <hr style="border: none; border-bottom: 1px solid black; border-top: 4px solid black; height: 10px; color: #ffffff; background-color: #ffffff; margin-left: auto; margin-right: auto;" align="center"><font style="font-size: 14pt;">UNITED STATES</font></div>
    <div style="text-align: center; font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-weight: bold;">SECURITIES AND EXCHANGE COMMISSION</div>
    <div style="text-align: center; font-family: 'Times New Roman',Times,serif; font-size: 12pt; font-weight: bold;">WASHINGTON, D.C. 20549</div>
    <div><br>
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    <div style="text-align: center; font-family: 'Times New Roman',Times,serif; font-size: 18pt; font-weight: bold;">FORM 6-K</div>
    <div><br>
    </div>
    <div style="text-align: center; font-weight: bold;">REPORT OF FOREIGN PRIVATE ISSUER</div>
    <div style="text-align: center; font-weight: bold;">PURSUANT TO RULE 13a-16 OR 15d-16</div>
    <div style="text-align: center; font-weight: bold;">UNDER THE SECURITIES EXCHANGE ACT OF 1934</div>
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    <div style="text-align: center; font-weight: bold;">For the month of February 2021</div>
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    <div style="text-align: center; font-weight: bold;">Commission File Number: 001-39461</div>
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    <div style="text-align: center; font-family: 'Times New Roman',Times,serif; font-size: 24pt; font-weight: bold;">NANO-X IMAGING LTD</div>
    <div><br>
    </div>
    <div style="text-align: center; font-weight: bold;">Communications Center</div>
    <div style="text-align: center; font-weight: bold;">Neve Ilan, Israel 9085000</div>
    <div style="text-align: center; font-weight: bold;">(Address of principal executive office)</div>
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    </div>
    <div>Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.</div>
    <div><br>
    </div>
    <div>Form 20-F &#9746; Form 40-F &#9744;</div>
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    </div>
    <div>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): &#9744;</div>
    <div><br>
    </div>
    <div>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.</div>
    <div><br>
    </div>
    <div>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): &#9744;</div>
    <div><br>
    </div>
    <div>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&#8217;s &#8220;home country&#8221;), or under the rules of the home country exchange on which the registrant&#8217;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&#8217;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.</div>
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      <div>On January 30, 2021, in connection with the FDA&#8217;s review of its 510(k) premarket notification for the single-source version of the Nanox.ARC, NANO-X IMAGING LTD (the &#8220;Company&#8221;) received additional information requests from the FDA which, among
        other things, require the Company to address certain deficiencies and questions, including requests that the Company provide additional support regarding the intended use of the Nanox.ARC and the comparability of the Nanox.ARC to the predicate
        device. The Company plans to respond to these requests promptly. In addition, the Company will continue to optimize and develop features of the Nanox.ARC, and plans to submit an additional 510(k) premarket notification to the FDA with respect to
        the multiple-source Nanox.ARC and the Nanox.CLOUD during 2021. If cleared by the FDA and authorized by similar regulatory agencies in other jurisdictions, the Company is targeting shipment of 1,000 Nanox Systems by the end of the first quarter of
        2022, with the goal to finalize deployment of the initial 15,000 Nanox Systems by the end of 2024.</div>
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    <div>The information contained in this report is hereby incorporated by reference into the Registration Statement on Form S-8, File No. 333-248322.</div>
    <div> <br>
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    <div>
      <div style="font-weight: bold;">Forward-Looking Statements</div>
      <div style="font-weight: bold;"> <br>
      </div>
      <div style="font-weight: bold;">
        <div style="font-family: 'Times New Roman',Times,serif; font-weight: normal;">This report may contain forward-looking statements that are subject to risks and uncertainties. All statements that are not historical facts contained in this report are
          forward-looking statements. Such statements include, but are not limited to, any statements relating to the initiation, timing, progress and results of the Company&#8217;s research and development, manufacturing and commercialization activities with
          respect to its X-ray source technology and the Nanox.Arc. In some cases, you can identify forward-looking statements by terminology such as &#8220;can,&#8221; &#8220;might,&#8221; &#8220;believe,&#8221; &#8220;may,&#8221; &#8220;estimate,&#8221; &#8220;continue,&#8221; &#8220;anticipate,&#8221; &#8220;intend,&#8221; &#8220;should,&#8221; &#8220;plan,&#8221;
          &#8220;should,&#8221; &#8220;could,&#8221; &#8220;expect,&#8221; &#8220;predict,&#8221; &#8220;potential,&#8221; or the negative of these terms or other similar expressions. Forward-looking statements are based on information the Company has when those statements are made or management&#8217;s good faith belief
          as of that time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Factors that
          could cause actual results to differ materially from those currently anticipated include: risks related to business interruptions resulting from the COVID-19 pandemic or similar public health crises could cause a disruption of the development,
          deployment or regulatory clearance of the Nanox System and adversely impact our business; the Company&#8217;s ability to successfully demonstrate the feasibility of its technology for commercial applications; the Company&#8217;s expectations regarding the
          necessity of, timing of filing for, and receipt and maintenance of, regulatory clearances or approvals regarding its X-ray source technology and the Nanox.Arc from regulatory agencies worldwide and its ongoing compliance with applicable quality
          standards and regulatory requirements; the Company&#8217;s ability to enter into and maintain commercially reasonable arrangements with third-party manufacturers and suppliers to manufacture the Nanox.Arc; the market acceptance of the Nanox.Arc and the
          proposed pay-per-scan business model; the Company&#8217;s expectations regarding collaborations with third-parties and their potential benefits; and the Company&#8217;s ability to conduct business globally, among others. Except as required by law, Nanox
          undertakes no obligation to update publicly any forward-looking statements after the date of this report to conform these statements to actual results or to changes&#160; in the Company&#8217;s expectations.</div>
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    <div style="text-align: center; font-weight: bold;">SIGNATURES</div>
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    <div style="text-indent: 36pt;">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.</div>
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        <tr>
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            <div style="font-family: 'Times New Roman', Times, serif;">NANO-X IMAGING LTD</div>
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          <td style="width: 50%; vertical-align: top;">&#160;</td>
          <td style="width: 5%; vertical-align: top;">&#160;</td>
          <td style="width: 45%; vertical-align: top;">&#160;</td>
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          <td style="width: 50%; vertical-align: top; padding-bottom: 2px;">&#160;</td>
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            <div style="font-family: 'Times New Roman', Times, serif;">By:</div>
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          <td style="width: 45%; vertical-align: top; border-bottom: 2px solid rgb(0, 0, 0);">
            <div style="font-family: 'Times New Roman', Times, serif;">/s/ Tal Shank</div>
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          <td style="width: 50%; vertical-align: top;">&#160;</td>
          <td style="width: 5%; vertical-align: top;">
            <div style="font-family: 'Times New Roman', Times, serif;">Name:</div>
          </td>
          <td style="width: 45%; vertical-align: top;">
            <div style="font-family: 'Times New Roman', Times, serif;">Tal Shank</div>
          </td>
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          <td style="width: 50%; vertical-align: top;">&#160;</td>
          <td style="width: 5%; vertical-align: top;">
            <div style="font-family: 'Times New Roman', Times, serif;">Title:</div>
          </td>
          <td style="width: 45%; vertical-align: top;">
            <div style="font-family: 'Times New Roman', Times, serif;">Vice President of Corporate Development</div>
          </td>
        </tr>

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    <div>Date: February 1, 2021</div>
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