CCI PACS VIEWER (PACS-US-001)

CCI PACS VIEWER (PACS-US-001) is an FDA 510(k)-cleared medical device (K254237) manufactured by CliniComp, Intl.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 22, 2026. Regulation: 8.