FDA Approves Viking’s Next Generation 3DHD Visualization System.

Viking Systems, Inc., a company providing advanced visualization solutions, announced that the United States Food and Drug Administration (FDA) has approved its new Next Generation 3DHD visualization system. The new solution is planned to be presented to the market at the American College of Surgeons' Annual Clinical Congress which will take place next October in Washington D.C.
Viking President & CEO, Jed Kennedy, said, "We are very pleased to have received timely FDA 510(k) clearance of our Next Gen system for a broad base of minimally invasive procedures including general surgery, urology, gynecology, spinal, bariatric, ENT and thoracic. With the 510(k) in place, we will now focus on completing the documentation required to apply the CE mark to the 3DHD system." The CE mark means that Viking’s Next Generation 3DHD is following the requirements of the Medical Device Directive of the European community. Kennedy added, "Because Viking is ISO13485-certified; we will be able to self-certify the 3DHD for the European community. This keeps us on track to be in the U.S. and European markets in the fourth quarter of 2010 as planned."......