
Kontron Medical Systems Sas
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SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K053084) manufactured by Kontron Medical Systems Sas. 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 15, 2005. Regulation: 8.