
Siemens Medical Solutions USA, Inc.
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MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM is an FDA 510(k)-cleared medical device (K050240) manufactured by Siemens Medical Solutions USA, 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 February 14, 2005. Regulation: 8.