GE, Volcano get 510(k) for integrated DR/US product

Multimodality vendor GE Healthcare and intravascular ultrasound (IVUS) developer Volcano of Rancho Cordova, CA, said that they have received U.S. Food and Drug Administration 510(k) clearance to integrate products.

The firms will combine Volcano's IVUS capabilities onto GE's Innova DR catheterization lab imaging system, according to Chalfont St. Giles, U.K.-based GE. The new imaging system will be marketed under the Innova IVUS name, GE said.

By AuntMinnie.com staff writers
August 24, 2006

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