FC-1000 FLUOROSCOPIC IMAGING COMPUTER

FC-1000 FLUOROSCOPIC IMAGING COMPUTER is an FDA 510(k)-cleared medical device (K854810) manufactured by Inficon Leybold-Heraeus, 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 April 14, 1986. Regulation: 8.