# K013484: Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging System, Niobe Electrophysiology Mapping Cath

- Pathway: 510(k) (Traditional)
- Applicant: Stereotaxis, Inc.
- Decided: May 2, 2002 after 195 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K900765 (1990). 3 ancestors in all.
39 later devices descend from it; 5 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924125: Cri Electronic Control System, Catheter Research C/O Burditt, Bowles & Radzius (1993) Summary page 2.
- K974355: Interventional Mobile Digital Imaging System (Herein Called Imdis), Ge Dec Medical Systems (1998) Summary page 2.
- K900765: Steerocath (TM), Ep Technologies, Inc. (1990) Summary page 2.

## Most influential descendants
- K021555: Stereotaxis Niobe Magnetic Navigation System (2003), 35 descendants of its own
- 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

## Indications for use
The 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. The Telstar™ Bi-plane Imaging System provides the utility of fluoroscopic imaging of vascular systems for applications including vascular angiography and electrophysiology (EP) studies. This x-ray system may be used stand-alone, or in conjunction with an associated Stereotaxis Magnetic Navigation System The Niobe EP Catheter is intended for intracardiac electrophysiological recording and/or stimulation for pacing in the right heart.

Source page: https://510kreport.com/device/K013484
Methodology: https://510kreport.com/methodology