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Date Announced: 15 Dec 2010
Application for marketing the system in the US is currently under review by the FDA.
FORT LAUDERDALE, Fla.--(BUSINESS WIRE)-- Imaging Diagnostic Systems, Inc. (IDSI) (OTCBB:IMDS.ob - News), a pioneer in laser breast imaging, announced today that it has received deposits for two CTLM systems from its distributor Mukesh Jain of Jainsons Pty Ltd for India and Indonesia. The first CTLM was installed last week at a private imaging center in Ahmedabad, India and the next system will be installed in January 2011.
The CTLM system is a laser based breast imaging system intended to provide the physician with physiological and clinical information non-invasively and without the use of ionizing radiation. The patient lays face down in the prone position comfortably on the scanning bed. The laser beam sweeps 360 degrees starting at the chest wall moving forward until the entire breast is scanned. The CTLM features 3-dimensional and Multiplanar views that display the distribution of blood supply within the vasculature structures of the breast. This information when interpreted by a trained radiologist can be useful in diagnostic determination.
The company submitted 510(k) application to the FDA for marketing clearance in the United States; the application is currently under review.
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.
Source: Imaging Diagnostic Systems
E-mail: see web site
Web Site: www.imds.com
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