# K032937: Navigant Magnetic Navigation Workstation 2.1 (NWS2) Model, 020-004500

- Pathway: 510(k) (Traditional)
- Applicant: Stereotaxis, Inc.
- Decided: Jul 1, 2004 after 283 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: 3 generations back to K900765 (1990). 5 ancestors in all.
4 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)
- K013484: Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging System, Niobe Electrophysiology Mapping Cath, Stereotaxis, Inc. (2002) Summary page 1.
- K021555: Stereotaxis Niobe Magnetic Navigation System, Stereotaxis, Inc. (2003) Summary page 1.

## Most influential descendants
- K051760: Navigant Workstation with Niobe Magnetic Navigation System, Model NWS05 (2006), 3 descendants of its own
- 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 Navigation Workstation 2.1 [NWS2] is a component of the Niobe® MNS. The Niobe® MNS with NWS2 is intended to navigate compatible magnetic devices 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/K032937
Methodology: https://510kreport.com/methodology