
Medical Insight A/S
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EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM is an FDA 510(k)-cleared medical device (K051809) manufactured by Medical Insight A/S. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 14, 2005. Regulation: 8.