
E-Z-Em, Inc.
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MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES is an FDA 510(k)-cleared medical device (K071378) manufactured by E-Z-Em, 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 June 12, 2007. Regulation: 8.