成像診斷系統公司（Imaging Diagnostic Systems, Inc.）日前宣布已經取得中國三套CT激光胸腔成像系統（CT Laser Breast imaging systems）的購買定單，該訂單具有信用証擔保。

CT激光胸腔成像系統是該公司擁有專利的胸腔成像系統，運用激光技朮和具有專利的運算法創建胸腔橫截面圖象和３維圖象，用于檢查癌症。該系統獲得了ＣＥ　Marking、ＵＬ Listing、ＩＳＯ９００１：２０００以及美國食品和藥物管理局的出口認証等多項認証。

成像診斷系統公司和其在中國的分銷商中國遠東國際貿易有限公司（China Far East International Trading Corp）已售出三套CT激光胸腔成像系統。

中國潛在的醫療設備市場巨大，多數專家認為，從某種意義上講，中國將會成為美國醫療設備出口商最大的單一國家市場。美國是中國進口醫療設備的首要進口國，中國進口的所有醫療設備中約有三分之一強來自美國。

Imaging Diagnostic Systems, Inc.（成像診斷系統公司）27日宣布，其 CT Laser Mammography (CTLM)(R) 系統已獲中國國家食品藥品監督管理局營銷批准。經過廣泛的審查，中國國家食品藥品監督管理局頒發了醫療設備認証注冊號，這是中國首個獲認可的基于激光的乳腺癌探測系統。該醫療設備的注冊號為20043241646

Imaging Diagnostic Systems 首席執行官Tim Hansen表示：“中國國家食品藥品監督管理局對我們設備的認可是我們全球商業化計划中的重要一步。中國是一個巨大的癌症探測設備市場，而自1966年以來癌症就成為主要的死亡原因。根據Globoscan 2000數據庫顯示，肺癌、乳腺癌及結腸癌的數量急劇上升。CTLM 的患者接受率應該較高，因為它使用無害放射線（僅為激光），而且對于女性來講該過程無痛，因為其并不擠壓甚至接觸乳房。27092004

China's FDA Approves IDSI Laser Breast Imaging Device
Monday September 27 2004, 9:30 am ET

FORT LAUDERDALE, Fla., Sept. 27 /PRNewswire-FirstCall/ -- Imaging Diagnostic Systems, Inc. (OTC Bulletin Board: IMDS - News) announced today that its CT Laser Mammography system (CTLM)R has received Chinese State Food and Drug Administration (SFDA) marketing approval. Following extensive inspection, the Peoples Republic of China SFDA issued the registration "Certificate for Medical Device," representing the first approved laser-based breast cancer detection system in China. The medical device registration number is 20043241646.
(Logo: http://www.newscom.com/cgi-bin/prnh/20040412/IMDSLOGO)
"The SFDA approval of our device is a major step in our global commercialization program. China is an enormous market for cancer detection devices since cancer became the leading cause of death in 1966. There has been a steep increase in the number of lung, breast, and colon cancers, according to the Globoscan 2000 database. CTLM patient acceptance should be high because it uses no harmful radiation, just laser light, and the procedure is painless for the woman since there is no compressing or even touching of the breast," stated Tim Hansen, CEO of Imaging Diagnostic Systems.

IDSI's exclusive distributor, China Far East International Trading Corporation (CFETC), has already received 4 CTLMR systems. CFETC is one of China's top 500 Enterprises in import and export volume. CFETC operates under the control of State-owned Assets Supervision and Administration Commission of the State Council. CFETC is located in Beijing with branches in Guangdong, Zhejiang, Jiangsu, Hainan, Fujian, Shenzhen, and Zhuhai.

Imaging Diagnostic Systems has received CE Marking, CMDCAS (Canada), Canadian License, China SFDA approval, UL listing, ISO 9001:2000-13488 certification and FDA export certification for its CT Laser Breast imaging system. The CTLMR system is the first patented breast-imaging system that utilizes state-of-the-art laser technology and patented algorithms to create 3-D cross-sectional images of the breast. The Company is seeking PreMarket Approval (PMA) from the Food and Drug Administration (FDA) for its CTLMR system to be used as an adjunct to mammography. The CTLMR system is a non- invasive, painless examination that does not expose the patient to radiation or require breast compression.

Please visit Imaging Diagnostic Systems' website at: http://www.imds.com for additional information.

In conjunction with 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 projected plans, performances and developments, as well as other statements relating to future operations. All such forward-looking statements are necessarily only estimates of future results and there can be no assurance that actual results will not materially differ from expectation. Further information on potential factors that could affect Imaging Diagnostic Systems, Inc., is included in the Company's filing with the Securities Exchange Commission.

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