# K021555: Stereotaxis Niobe Magnetic Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Stereotaxis, Inc.
- Decided: Jan 15, 2003 after 247 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: 2 generations back to K900765 (1990). 4 ancestors in all.
35 later devices descend from it; 4 cite it directly.
0 of 40 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)

## Most influential descendants
- K052480: Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical Steerable Guide Catheter (SGC) and Sheath (2007), 27 descendants of its own
- K073225: Sensei Catheter Control System (2008), 24 descendants of its own
- K090365: Hansen Medical Artisan S Control Catheter (2009), 22 descendants of its own
- K091808: Sensei Robotic Catheter System, Model 02057 (2009), 19 descendants of its own
- K102168: Sensei X Robotic Catheter System (2010), 12 descendants of its own

## Indications for use
The Niobe MNS is intended to navigate a 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.

Source page: https://510kreport.com/device/K021555
Methodology: https://510kreport.com/methodology