
Siemens Medical Solutions USA, Inc.
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SYNGO COLONOGRAPHY SOFTWARE PACKAGE is an FDA 510(k)-cleared medical device (K030982) 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 April 7, 2003. Regulation: 8.