510(k) K051760

NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05 by Stereotaxis, Inc. — Product Code DXX

K051760 is an FDA 510(k) premarket notification submitted by Stereotaxis, Inc. for the device "NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05". The FDA issued a decision of Substantially Equivalent on May 5, 2006. The device falls under product code DXX (System, Catheter Control, Steerable), a Class II device regulated under 21 CFR 870.1290. Stereotaxis, Inc. has at least 10 other 510(k) clearances on record.