510(k) Report

Devices descending from K183027

2 later devices reach Steerable catheter control system through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192775Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriStereotaxis, Inc.201911
+2K193147Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemStereotaxis, Inc.20200—