EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS

EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS is an FDA 510(k)-cleared medical device (K954646) manufactured by Philips Medical Systems (Cleveland), 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 January 17, 1996. Regulation: 8.