VINGMED SOUND COLOR FLOW MAPPING SYSTEM. SYSTEM FIVE

VINGMED SOUND COLOR FLOW MAPPING SYSTEM. SYSTEM FIVE is an FDA 510(k)-cleared medical device (K963315) manufactured by Vingmed Sound, 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 March 16, 1997. Regulation: 8.