CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105

CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105 is an FDA 510(k)-cleared medical device (K961690) manufactured by Continental X-Ray 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 26, 1996. Regulation: 8.