| Thursday, July 29, 2010 | |||
| NEWSRoom | |||
| 11/27/2000 | |||
| Source: Imaging Diagnostic Systems, Inc. | |||
Imaging Diagnostic Systems Announces CE Marking Recommendation At RSNA 2000 |
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Rate It! "The recommendation for CE Marking and the significant improvement of our image quality due to algorithm enhancements and color-enhanced three dimensional imaging will make this our most memorable RSNA conference to date," stated Richard Grable, CEO and Director of Research and Development. This assessment is based on the requirements found in the European harmonized standard EN 46002:1996, the International standard EN/ISO 9002:1994, the International standard EN/ISO 13488:1996 and the 93/42/EEC of the Medical Device Directive. The CTLM(R) images displayed at RSNA 2000 are from the Company's FDA- approved clinical studies. "I know of no other imaging modalities or diagnostic tools available today that can clearly separate and outline a tumor mass the way the CTLM(R) system can through three dimensional color-enhanced imaging," stated David Richter, M.D., Medical Director of Imaging Diagnostic Systems. Imaging Diagnostic Systems is simultaneously seeking Pre-Market Approval (PMA) from the FDA for its CTLM(R) to be used as an adjunct to mammography. The Company has submitted its first module as a part of the Modular submission process and expects to complete this process by early 2001. Imaging Diagnostic Systems, Inc. has developed the world's first patented laser-based breast imaging system that utilizes state-of-the-art laser technology and proprietary and patented algorithms to create three-dimensional cross sectional images of the breast. The CTLM(R) is a non-invasive, painless examination that does not expose the patient to radiation or require breast compression. |
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