
Agfa Healthcare Corp.
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IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION) is an FDA 510(k)-cleared medical device (K071297) manufactured by Agfa Healthcare Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 21, 2007. Regulation: 8.