-----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, FQEZVnfV0PYyamXa/FOqk4rA+7Kh+Ln6sAdUxpQqokwUy9o+ky9z6FCHcec6e4pb WFT19x0RfQyFz0i2GR6HDw== 0000790652-10-000024.txt : 20101123 0000790652-10-000024.hdr.sgml : 20101123 20101123171426 ACCESSION NUMBER: 0000790652-10-000024 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20101122 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20101123 DATE AS OF CHANGE: 20101123 FILER: COMPANY DATA: COMPANY CONFORMED NAME: IMAGING DIAGNOSTIC SYSTEMS INC /FL/ CENTRAL INDEX KEY: 0000790652 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 222671269 STATE OF INCORPORATION: FL FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-26028 FILM NUMBER: 101212379 BUSINESS ADDRESS: STREET 1: 5307 NW 35TH TERRACE CITY: FORT LAUDERDALE STATE: FL ZIP: 33309 BUSINESS PHONE: 954 581-9800 MAIL ADDRESS: STREET 1: 5307 NW 35TH TERRACE CITY: FORT LAUDERDALE STATE: FL ZIP: 33309 FORMER COMPANY: FORMER CONFORMED NAME: ALKAN CORP DATE OF NAME CHANGE: 19940623 8-K 1 form8-k_112310.htm CURRENT REPORT ON FORM 8-K form8-k_112310.htm
 


 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

November 22, 2010
----------------
Date of Report
(Date of Earliest Event Reported)


IMAGING DIAGNOSTIC SYSTEMS, INC.
------------------------------------------------------
(Exact name of registrant as specified in its charter)
 
IDSI Logo

Florida
0-26028
22-2671269
     
(State or Other Jurisdiction of
(Commission File Number)
(I.R.S. Employer
Incorporation or Organization)
 
Identification Number)

5307 NW 35TH TERRACE
FORT LAUDERDALE, FL 33309
--------------------------------------------------
(Address of principal executive offices)


(954) 581-9800
-----------------------------------------
(Registrant’s telephone number)

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 CFR 230.425)

[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12)

 
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.  (17 240.14d-2(b))

 
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.  (17 240.13e-4(c))

 
 

 


Item 8.01
Other Events

On November 22, 2010, Imaging Diagnostic Systems, Inc. (the “Company”) submitted a Premarket Notification 510(k) to the United States Food and Drug Administration (FDA).  With this submission, the Company moves forward in the process of seeking U.S. marketing clearance for its innovative breast imaging device, the CTLM® system.

The Company will continue to market the CTLM® system internationally and work with its international clinical sites, where the system has gained approval. The documentation and the data submitted to the FDA will now officially enter the 510(k) review process.


A press release announcing the Company’s filing of its 510(k) application with the FDA is furnished as an exhibit to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated by reference.


Item 9.01
Financial Statements and Exhibits

(c) Exhibits

99.1
 
Press Release dated November 23, 2010


SIGNATURES

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

    IMAGING DIAGNOSTIC SYSTEMS, INC.

Dated:  November 23, 2010


/s/ Allan L. Schwartz

By: Allan L. Schwartz
Executive Vice President
Chief Financial Officer
 
 
 


EX-99.1 2 exhbit99-1.htm PRESS RELEASE 11-23-10 exhbit99-1.htm
 


 
Exhibit 99.1

IMAGING DIAGNOSTIC SYSTEMS ANNOUNCES FILING OF 510(k) SUBMISSION TO FDA

Company is Seeking Marketing Clearance for Its CT Laser Mammography System (CTLM®) in the US

Fort Lauderdale, Florida, November 23, 2010—Imaging Diagnostic Systems, Inc., (IDSI) (OTCBB: IMDS) a pioneer in laser breast imaging, announced today that a Premarket Notification 510(k) was submitted on Monday, November 22, 2010, to the United States Food and Drug Administration (FDA).  With this submission, the company moves forward in the process of seeking marketing clearance for its innovative breast imaging device, the CTLM system.
 
The CTLM system is an innovative breast imaging device intended to aid in the diagnosis of breast cancer in a non-invasive procedure. The patient lies face down comfortably on the scanning bed for approximately 10 minutes until the scan is completed. CTLM uses state-of the-art laser technology and proprietary computed algorithms instead of x-rays and breast compression to create three-dimensional views of the blood supply in the breast.  These images can be used to complement current breast imaging modalities, providing additional information on the nature of breast abnormalities.
 
 
“This submission is a significant step toward the realization of our dream of marketing this unique breast imaging device throughout the United States,” stated Linda Grable, CEO of Imaging Diagnostic Systems. “CTLM has the potential to be a significant addition to breast imaging facilities, especially in difficult cases, like patients with dense breasts. We are committed to getting this product to market as quickly as possible, while simultaneously developing strong distribution channels and marketing resources for its launch."
 
 
As breast cancer is the most common cancer in women worldwide, the emphasis on breast cancer screening and detection has steadily increased. According to the World Health Organization, survival rates vary widely throughout the world, from more than 80 percent in the United States, Sweden, and Japan, to under 40 percent in poorer countries. In the face of these statistics, along with the benefits that the CTLM system offers to women and their physicians, the system is rapidly gaining international recognition.
 
 
Imaging Diagnostic Systems will continue to market the CTLM system and to work with its international clinical sites, where the system has gained approval. The documentation and the data submitted to the FDA will now officially enter the 510(k) review process.
 
The CTLM system has received certification and licenses European CE marking, CMDCAS Canadian License, China SFDA, UL, ISO 9001:2000, ISO 13485:2003 and FDA export certification.

For more information, visit our website: http://www.imds.com.

As contemplated by the provisions of the Safe Harbor section of the Private Securities Litigation Reform Act of 1995, this news release may contain forward-looking statements pertaining to future, anticipated, or projected plans, performances and developments, as well as other statements relating to future operations. All such forward-looking statements are necessarily only estimates or predictions of future results or events and there can be no assurance that actual results or events will not materially differ from expectations. Further information on potential factors that could affect Imaging Diagnostic Systems, Inc., is included in the Company's filings with the Securities and Exchange Commission. We expressly disclaim any intent or obligation to update any forward-looking statements.

Contact:
Deborah O’Brien
954.257.8940
 
 
 
 


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-----END PRIVACY-ENHANCED MESSAGE-----