EPIC (ELECTROPHYSIOLOGY IMAGING COMPUTER

EPIC (ELECTROPHYSIOLOGY IMAGING COMPUTER is an FDA 510(k)-cleared medical device (K926560) manufactured by Fischer Imaging 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 May 8, 1994. Regulation: 8.