GATED MIBI 3-D EJECTION FRACTION PROCESSING

GATED MIBI 3-D EJECTION FRACTION PROCESSING is an FDA 510(k)-cleared medical device (K961597) manufactured by Trionix Research Laboratory, 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 September 3, 1996. Regulation: 8.