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SenoBright CESM is 510(k) pending

GE Healthcare announces today that it is 510(k) pending approval from the FDA on its SenoBright Contrast Enhanced Spectral Mammography (CESM). David Caumartin, General Manager for Mammography at GE Healthcare, shares all the details from GE Healthcare's RSNA 2010 booth.

The SenoBright option cannot be put into service in countries that require the CE mark until it has been made to comply with CE marking. It may not be available in all regions. SenoBright Contrast Enhanced Spectral Mammography (CESM) is 510(k) pending at the FDA. Not available for sale in the United States.