AMICAS VISION SERIES PACS, MODEL 4.3

AMICAS VISION SERIES PACS, MODEL 4.3 is an FDA 510(k)-cleared medical device (K062477) manufactured by Amicas, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 26, 2006. Regulation: 8.