-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, BwdBt/3klO+LbeeY80+WXNb7ytc7gSplivwsMmWnSYMzbqdB3vE0DfiZ5JG57XRW /oHPWg+VeTXXLeW16Agw+Q== 0001065949-10-000188.txt : 20101101 0001065949-10-000188.hdr.sgml : 20101101 20101101162853 ACCESSION NUMBER: 0001065949-10-000188 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20101101 ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20101101 DATE AS OF CHANGE: 20101101 FILER: COMPANY DATA: COMPANY CONFORMED NAME: IMAGING3 INC CENTRAL INDEX KEY: 0001205181 STANDARD INDUSTRIAL CLASSIFICATION: X-RAY APPARATUS & TUBES & RELATED IRRADIATION APPARATUS [3844] IRS NUMBER: 954451059 STATE OF INCORPORATION: CA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-50099 FILM NUMBER: 101155250 BUSINESS ADDRESS: STREET 1: 3200 W. VALHALLA DRIVE CITY: BURBANK STATE: CA ZIP: 91505 BUSINESS PHONE: 8182600930 MAIL ADDRESS: STREET 1: 3200 W. VALHALLA DRIVE CITY: BURBANK STATE: CA ZIP: 91505 8-K 1 i38knov12010.txt UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 1, 2010 IMAGING3, INC. ---------------------------------------------------------- (Exact name of registrant as specified in its charter) CALIFORNIA --------------------------------------------- (State or other jurisdiction of incorporation) 000-50099 95-4451059 - ------------------------ ------------------------------------ (Commission File Number) (I.R.S. Employer Identification No.) 3200 W. VALHALLA DR., BURBANK, CALIFORNIA 91505 -------------------------------------------------------------------- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (818) 260-0930 -------------- NOT APPLICABLE - ----------------------------------------------- (Former name, former address and former fiscal year, if changed since last report) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions. [_] Written communications pursuant to Rule 425 under the Securities Act (17 CFR240.14d-2(b)) [_] Soliciting material pursuant to Rule 14a-12 under Exchange Act (17 CFR240.14a-12) [_] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR240.14d-2(b)) [_] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR240.13e-4(c)) TABLE OF CONTENTS SECTION 7. REGULATION FD..................................................1 Item 7.01 Regulation FD Disclosure..................1 SECTION 9. FINANCIAL STATEMENTS AND EXHIBITS .............................1 SIGNATURES..................................................................2 SECTION 7. REGULATION FD Item 7.01. Regulation FD Disclosure. On October 25, 2010, The Company received a letter from the United States Food and Drug Administration (the "FDA"), date stamped October 22, 2010, responding to the Company's application to the FDA for clearance of its 3D medical imaging technology and device. In its application to the FDA under Section 510(k) of the applicable federal legislation, the Company states that its medical device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976 and therefore should be approved for commercial sale and use as a Class II device, without the necessity for clinical trials. The FDA responded by rejecting the Company's position that its medical device is substantially equivalent to such prior devices. The Company disagrees with the FDA's position and plans to refile its application with additional information supporting the Company's application for clearance. In order to strengthen its next submission to the FDA, the Company may engage an outside independent professional consulting firm having extensive prior experience with the FDA in order to achieve a substantial equivalence determination from the FDA for the Company's medical device and thereby attain its approval for commercial sale and use. While we remain confident of eventually achieving FDA approval of the Company's medical device as a Class II device, there is no assurance that such approval will be obtained or that the Company may not ultimately be required to file it under Class III where clinical trials would be required. SECTION 9. FINANCIAL STATEMENTS, PRO FORMA FINANCIALS & EXHIBITS (a) Financial Statements of Business Acquired Not Applicable. (b) Pro Forma Financial Information Not Applicable. (c) Shell Company Transactions Not Applicable. (d) Exhibits None. -1- SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. IMAGING3, INC. ------------------- (Registrant) Date: November 1, 2010 /s/ Dean Janes, Chief Executive Officer ------------------------------------------------------ Dean Janes, Chief Executive Officer -2- -----END PRIVACY-ENHANCED MESSAGE-----