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.
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(Exact name of registrant as specified in its charter)
CALIFORNIA
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(State or other jurisdiction of incorporation)
000-50099 95-4451059
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(Commission File Number) (I.R.S. Employer Identification No.)
3200 W. VALHALLA DR., BURBANK, CALIFORNIA 91505
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (818) 260-0930
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NOT APPLICABLE
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(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.
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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.
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(Registrant)
Date: November 1, 2010
/s/ Dean Janes, Chief Executive Officer
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Dean Janes, Chief Executive Officer
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