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Viatronix, Inc.
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VIATRONIX V3D-CARDIAC, REVISION 1.0 is an FDA 510(k)-cleared medical device (K083293) manufactured by Viatronix, 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 December 4, 2008. Regulation: 8.