SMART VESSEL ANALYSIS (SMART VA) OPTION

SMART VESSEL ANALYSIS (SMART VA) OPTION is an FDA 510(k)-cleared medical device (K993792) manufactured by Ge Medical Systems, 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 November 23, 1999. Regulation: 8.