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FDA OKs GE Medical Systems Innova 4100
Nov 2002
WAUKESHA, Wis., Nov. 28 -- GE Medical Systems announced it has received 510(k) market clearance from the US Food & Drug Administration (FDA) for the GE Innova 4100, a large-format digital flat panel x-ray system that provides detailed, real-time fluoroscopic images of human anatomy for radiological procedures.

GE said the Innova 4100 is expected to help physicians treat a variety of medical disorders, including peripheral vascular, cardiovascular and neurological diseases, uterine fibroids, without major surgery. With the Innova 4100, physicians will be able to see clearly inside a patient with digital real-time imaging while guiding catheters and other medical devices to areas of the body needing treatment.

According to Hal Folander, MD, Chief of Radiology at St. Luke's Hospital & Health Network in Bethlehem, Penn., the GE Innova 4100 opens a new era for a wide range of interventional care by producing clearer fluoroscopic images with a larger field of view. "This new technology will help physicians around the world further advance the effectiveness of interventional procedures," said Folander, who led the study of the Innova 4100 during clinical trials of the system. "Images created by the GE Innova 4100 provide us with the most detailed and efficient information we have ever had."

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