Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)

Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) is an FDA 510(k)-cleared medical device (K251792) 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 November 5, 2025. Regulation: 8.