
Medison America, Inc.
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SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K012867) manufactured by Medison America, 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 11, 2001. Regulation: 8.