Biospace files 510(k) application

French digital radiography developer Biospace Med has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its EOS orthopedic 2D/3D x-ray imager.

EOS has recently received the European CE Mark, as well as approval from the Health Canada Medical Device Bureau, according to the Paris-based firm.

By AuntMinnie.com staff writers
July 9, 2007

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