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|Articles|May 14, 2008

FDA clears GE’s new CT scanner

As the exhibit floor at the Stanford International Symposium on Multidetector-Row CT was ready to open May 13, GE booth managers strategically placed signs announcing the FDA clearance of its new LightSpeed CT750 HD atop displays of the scanner’s components.

As the exhibit floor at the Stanford International Symposium on Multidetector-Row CT was ready to open May 13, GE booth managers strategically placed signs announcing the FDA clearance of its new LightSpeed CT750 HD atop displays of the scanner's components.

Word of the FDA decision arrived just the day before the floor opened. Regulators approved all claims made in the company's 510(k) submission, according to the company, including ones addressing markedly improved resolution and reduced x-ray dose to the patient. The company formally launched the scanner that evening as part of a meet and greet, during which GE executive Gene Saragnese and GE luminaries described the new system and its clinical potential.


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