# K051760: Navigant Workstation with Niobe Magnetic Navigation System, Model NWS05

- Pathway: 510(k) (Traditional)
- Applicant: Stereotaxis, Inc.
- Decided: May 5, 2006 after 310 days
- Product code: DXX (System, Catheter Control, Steerable)
- Device class: 2
- Regulation: 21 CFR 870.1290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K900765 (1990). 6 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032937: Navigant Magnetic Navigation Workstation 2.1 (NWS2) Model, 020-004500, Stereotaxis, Inc. (2004) Summary page 1.

## Most influential descendants
- K183027: Steerable catheter control system (2019), 2 descendants of its own
- K192775: Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri (2019), 1 descendant of its own
- K193147: Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System (2020), 0 descendants of its own

## Indications for use
The Navigant TM Workstation with Niobe® Magnetic Navigation System is intended to navigate a compatible magnetic device through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant TM feature provides an enhanced navigation interface for the physician to control the MNS.

Source page: https://510kreport.com/device/K051760
Methodology: https://510kreport.com/methodology