ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A

ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A is an FDA 510(k)-cleared medical device (K991766) manufactured by Toshiba America Medical Systems, In.C. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 9, 1999. Regulation: 8.