**** OTCQB-IMDS IS GAINING GROUND HERE! ****
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**** OTCQB:IMDS IS GAINING GROUND HERE! ****
[1]www.steroidstocks.com Recently, [2]I[3]maging Diagnostic Systems, Inc.[4] – ([5]OTCQB:IMDS) announced [6]the CTLM is a New and Unique Imaging Technology Best Described as `Diffuse Optical Tomography` (DOT) Imaging Diagnostic Systems, Inc., (IDSI) ([7]OTCQB:IMDS) – a pioneer in optical breast imaging announced that it has received notification from the Food and Drug Administration (FDA) that the review of the company`s Section 510(k) pre-market notification application of its CTLM system has been completed and categorized as a Class III device requiring a Premarket Approval application.
The FDA determined that the CTLM device is not substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, or to any device which has been reclassified into a class I (General Controls) or class II (Special Controls) or to any device found to be substantially equivalent through the 510 (k) process.
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 is positioned 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 Multi-planar 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 CTLM system has received certification and licenses to sell internationally European CE marking, CMDCAS Canadian License, China SFDA, UL, ISO 9001:2000, ISO 13485:2003 and FDA export certification. The company`s traditional 510(k) application is pending review from the Food and Drug Administration for marketing clearance in the United States.
For more information visit [8]www.imds.com.
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References 1. http://www.steroidstocks.com/
2. http://www.imds.com/
3. http://www.imds.com/
4. http://www.imds.com/
5. http://www.imds.com/
6. http://finance.yahoo.com/news/The-CTLM-is-a-New-and-Unique-bw-1515048836.htmlx=0&.v=1 7. http://www.imds.com/
8. http://www.imds.com/
9. http://www.steroidstocks.com/disclaimer/
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