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GE Healthcare
FDA Gives Green Light to GE Healthcare Surgery; Shipping Resumes
May 18th, 2008
The United States Food and Drug Administration (FDA) has notified GE Healthcare's Surgery business, headquartered in Salt Lake City, Utah, that the company has satisfied the criteria in the January 2007 consent decree required to resume operations. The OEC(R) 9900 Elite C-arm, a fluoroscopy device that uses x-rays to reveal real-time imagery of a patient's internal structure, is the first product to receive manufacturing and shipping authorization. More than 300 of these units will be shipped to customers in the first 10 days of operations. "Above all, this is a great day for our customers," said Joe Hogan, President and CEO of GE Healthcare. "We'd like to thank the...
Source: Medical Letter on the CDC & FDA (2008-05-18)
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