Mercury Computer Systems, Inc. (NASDAQ: MRCY) announced that the Food and Drug Administration (FDA) has granted clearance to market Visage(TM) PACS and Visage CS (picture archiving and communications system and client server) products as medical devices in the United States.

For more than a decade, Mercury has sold computer systems and software as components to medical diagnostic imaging OEMs. In June, Mercury's Commercial Imaging and Visualization group received ISO 13485 certification for its quality management system for medical devices.

"FDA approval of Visage PACS and Visage CS demonstrates Mercury's commitment to provide medical-quality products, developed under the control of a medical-grade quality management system, for the benefit of our partners' product development and regulatory approval cycle," said Marcelo Lima, Vice President and General Manager of Commercial Imaging and Visualization at Mercury Computer Systems.

Visage PACS and Visage CS are fully scalable medical image management and distribution solutions that enable clinicians and radiologists to seamlessly utilize the 3D functionality of Visage CS while benefiting from the intuitive workflow from Visage PACS. The Visage products offer a best in class, high- performance 2D/3D diagnostic image management system. With the use of Visage PACS and Visage CS, a virtually unlimited number of medical professionals can securely view images within the hospital network and over the web on any standard PC connected to the network, whether within or outside the department or institution.

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