
Stereotaxis, Inc.
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NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION is an FDA 510(k)-cleared medical device (K060967) manufactured by Stereotaxis, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 18, 2006. Regulation: 8.