Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System

Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System is an FDA 510(k)-cleared medical device (K193147) 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 March 4, 2020. Regulation: 8.