Vdrive system, Vdrive Duo, Vdrive with V-Sono

Vdrive system, Vdrive Duo, Vdrive with V-Sono is an FDA 510(k)-cleared medical device (K150312) 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 June 16, 2015. Regulation: 8.