
Siemens Medi Cal Solutions, Inc.
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ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K093531) manufactured by Siemens Medi Cal Solutions, 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 30, 2009. Regulation: 8.