Printer Friendly
The Free Library
14,497,001 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Imaging3 Scheduled to File with the FDA.


Important Milestone Scheduled to Start by Mid-June 2007

BURBANK, Calif. -- Imaging3[TM], Inc. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:IMGG IMGG Institute of Marine Geology and Geophysics ), developer of a breakthrough medical imaging device that produces 3D medical diagnostic images of virtually any part of the human body in real-time, announced today that it expects to file a 510(k) submission with the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 by June 15th for the Dominion(TM) 3D real-time imaging 'real-time' imaging Visualization of a dynamic process µsecs after occurring, which requires rapid information processing–ie, as the process occurs, as in 'B' mode ultrasound  device.

The FDA 510(k) submission is a device equivalent submission comparing the Functionality, Intended Use and Energy Transmission with similar devices currently on the market. The process can take 6 months or more depending upon the complexity of the product and quality of the application. "We're extremely excited to be ready to file our 510(k) submission with the FDA. We hope to obtain FDA approval by year-end, but understand the process could continue into 2008. We have generated enough data through our initial stages of Beta Testing (programming) beta testing - Testing a pre-release (potentially unreliable) version of a piece of software by making it available to selected users. This term derives from early 1960s terminology for product cycle checkpoints, first used at IBM but later standard throughout the  that we are now confident we can proceed with the FDA filing," stated Dean Janes, Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. .

Mr. Janes also pointed out that "off-the-shelf" components are used, such as the X-Ray source and Image Receptor, in the Dominion, and stated further, "While it is no guarantee, the fact that we are using 'off-the shelf' components known to the FDA, it should help to speed the approval process along." Mr. Janes concluded his remarks by pointing out that this will be the fourth Fluoroscopy fluoroscopy /flu·o·ros·co·py/ (fldbobr-ros´kah-pe) examination by means of the fluoroscope.

fluo·ros·co·py
n.
Examination by means of a fluoroscope. Also called radioscopy.
 based device that he has guided through the FDA 510(k) approval process.

About Imaging3

Imaging3, Inc., founded in 1993, is a leading provider of advanced technology medical imaging devices. The Company has developed a breakthrough medical imaging device that produces 3D medical diagnostic images of virtually any part of the human body in real-time. Because these 3D images are instantly constructed in real-time, they can be used for any current or new medical procedures in which multiple frames of reference are required to perform medical procedures on or in the human body. Visit the company's website at http://www.imaging3.com for more information

Safe Harbor Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
 Statement

Matters discussed in this press release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. When used in this press release, the words "anticipate," "believe," "estimate," "may," "intend," "expect" and similar expressions identify such forward-looking statements. Actual results, performance, or achievements could differ materially from those contemplated, expressed, or implied by the forward-looking statements contained herein. These forward-looking statements are based largely on the expectations of the Company and are subject to a number of risks and uncertainties. These include, but are not limited to, risks and uncertainties associated with: the impact of economic, competitive, and other factors affecting the Company and its operations, markets, product, and distributor performance, the impact on the national and local economies resulting from terrorist actions, and U.S. actions subsequently; and other factors detailed in reports filed by the Company.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:Jun 5, 2007
Words:485
Previous Article:GE Completes Agreement for Sophos's Integrated Security & Control Solution.
Next Article:Children Are Becoming Exposed To and Adopting Electronic Devices at Earlier Ages.
Topics:



Related Articles
NEOPATH(R) INC.'S PMA APPLICATION SCHEDULED FOR PANEL HEARING BY FDA.
To tell the truth. (Food and Drug Administration's labeling laws)
Biopsys Medical Responds to FDA Labeling Request; Company Fully Supports FDA's Efforts to Create Consistent Breast Biopsy Device Labeling.
Developer of Cancer Drug Sues the FDA.(American BioScience Inc.)(Brief Article)
Unusual skin lesions in chronic myelomonocytic leukemia. (Case Report).
Nutcracker in Italy.(Letters)(Letter to the Editor)
Peroxide cured HNBR/methacrylate blends with improved low temperature performance.
Imaging3 filling wide-open space in medical diagnostics.(Public Companies)
Imaging3 and Oregon Health & Science University to Partner as First Luminary Site for the Dominion.
Imaging3 CEO to be Interviewed on Internet Investor Site Market News First.

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles