stereotaxis.comStereotaxis GenesisX RMN with Navigant ? Workstation (NWS)
Stereotaxis, Inc.
STEREOTAXIS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3003084417 | 3003084417 | STEREOTAXIS, INC. | 1 | N | 2026-01-01 | 710 N. Tucker Blvd., Suite 110 Saint Louis MO US 63101 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| M588001004115110 | Cardiodrive System - The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. | 13146786100 | info@stereotaxis.com |
| M588001004115120 | Cardiodrive System - The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. | 13146786100 | info@stereotaxis.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 59831 | 1856688661 | P240014 | MAGiC Ablation Catheter | LPB | 2026-01-05 |
| 59831 | 1079046906 | K251792 | Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) | DXX | 2025-11-06 |
| 59831 | 1291271560 | K193147 | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System | PJB | 2020-03-05 |
| 59831 | 1086521175 | K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri | PJB | 2019-10-30 |
| 59831 | 1753160422 | K150312 | Vdrive system, Vdrive Duo, Vdrive with V-Sono | DXX | 2015-06-17 |
| 59831 | 1503724748 | K141530 | VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS | DXX | 2014-12-18 |
| 59831 | 2031835693 | K140804 | VDRIVE WITH V-LOOP/ VDRIVE DUO | DXX | 2014-09-03 |
| 59831 | 1045182920 | K133396 | VDRIVE WITH V-SONO | DQX | 2014-02-06 |
| 59831 | 1638739304 | K122659 | VDRIVE W/V-SONO | DQX | 2013-07-26 |
| 59831 | 1606842181 | K093092 | ODYSSEY WORKSTATION | DQK | 2010-01-21 |
| 59831 | 2051785781 | K072371 | ODYSSEY WORKSTATION | DXX | 2007-11-14 |
| 59831 | 1666462778 | K071029 | CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS) | DQX | 2007-08-24 |
| 59831 | 1471315869 | K060967 | NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION | NDQ | 2006-10-19 |
| 59831 | 1895911417 |
Product Codes Associated With Registrations#
PMN#
Stereotaxis Genesis RMN With Navigant Workstation (NWS) And Cardiodrive System
Stereotaxis, Inc.
Niobe® Magnetic Navigation System (MNS) With Navigant Workstation (NWS) And Cardiodri
Stereotaxis, Inc.
Steerable Catheter Control System
Stereotaxis, Inc.
Vdrive System, Vdrive Duo, Vdrive With V-Sono
STEREOTAXIS, INC.
VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS
STEREOTAXIS, INC.
VDRIVE WITH V-LOOP/ VDRIVE DUO
STEREOTAXIS, INC.
VDRIVE WITH V-SONO
STEREOTAXIS, INC.
VDRIVE W/V-SONO
STEREOTAXIS, INC.
ODYSSEY WORKSTATION
STEREOTAXIS, INC.
POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS
STEREOTAXIS, INC.
ODYSSEY WORKSTATION
STEREOTAXIS, INC.
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)
STEREOTAXIS, INC.
NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION
STEREOTAXIS, INC.
NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05
STEREOTAXIS, INC.
CRONUS GUIDEWIRE, MODEL 001-001470-1
STEREOTAXIS, INC.
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM
STEREOTAXIS, INC.
MODIFICATION TO ENDOVASCULAR GUIDE WIRE
STEREOTAXIS, INC.
STEREOTAXIS ENDOVASCULAR GUIDE WIRE
STEREOTAXIS, INC.
NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500
STEREOTAXIS, INC.
STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM
STEREOTAXIS, INC.
ENDOVASCULAR GUIDE WIRE
STEREOTAXIS, INC.
TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915
STEREOTAXIS, INC.
TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH
STEREOTAXIS, INC.
GUDID#
Navigant - The Navigant Workstation (NWS) is a component of the Magnetic Navigation System (MNS). The MNS with NWS 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 feature provides an enhanced navigation interface for the physician to control the MNS.
2026-07-03
Niobe MNS Omega - Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Navigation Workstation. The Niobe MNS with Navigant NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction.
2026-04-23
GenesisX - Stereotaxis GenesisX RMN with Navigant™ Workstation (NWS) and Cardiodrive® System (GenesisX) is an interventional workstation for the intravascular navigation of appropriately equipped, magnetically adapted, devices (e.g., catheters or guidewires) using computer-controlled permanent magnets to orient or steer the tip of a magnetic device, and remotely advance and retract only compatible magnetic electrophysiology (EP) catheters inside the patient’s heart. GenesisX incorporates software that determines the direction the magnetic field should be applied based on physician interaction with the user interface devices.
2026-01-09
Cardiodrive System - The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.
2022-06-06
Cardiodrive System - The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.
2022-06-06
Genesis (RMNS) - Genesis RMNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right andleft heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desireddirection.
2020-08-20
Genesis MNS with Model-S - """Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right andleft heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desireddirection. """
2020-08-20
Navigant - The Navigant Navigation Workstation is a component of the Niobe MNS. The Niobe MNS with NWS 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 feature provides an enhanced navigation interface for the physician to control the MNS
2016-08-01
Navigant - The Navigant Navigation Workstation is a component of the Niobe MNS. The Niobe MNS with NWS 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 feature provides an enhanced navigation interface for the physician to control the MNS
2016-08-01
Navigant - The Navigant Navigation Workstation is a component of the Niobe MNS. The Niobe MNS with NWS 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 feature provides an enhanced navigation interface for the physician to control the MNS
2016-10-27
Odyssey - The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab
2016-08-01
Hemostasis Adapter - Hemostasis Adapter IV Spares, Box, Device Count(5)
2021-12-14
Cinema MAS & MMS - The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab
2016-08-01
QuikCAS Cardiodrive Sterile Components - The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.
2016-05-02
QuikCAS Hemostasis Adapter - The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.
2016-08-01
Cardiodrive Hemostasis Adapter - SJ - The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.
2016-08-01
Vdrive System - """The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during theperformance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system, • Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance ofelectrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and • Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when usedin conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic NavigationSystem (MNS). """
2016-08-01
Vdrive System - """The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during theperformance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system, • Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance ofelectrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and • Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when usedin conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic NavigationSystem (MNS). """
2016-08-01
V-CAS Catheter Advancement System - The Vdrive with V-CAS Disposable is indicated for remotely controlling the advancement, retraction, and rotation of compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System
2016-05-02
V-Loop Variable Loop Catheter Manipulator - The Vdrive with V-Loop disposable is indicated to remotely control the advancement, retraction, rotation, tip deflection and loop size of compatibile loop catheters inserted across the septum into the left atrium using conventional procedures
2016-05-02
V-Sono Intracardiac Echo Manipulator - Vdrive with V-Sono is indicated for remotely controlling the advancement, retraction, rotation and anterior-posterior deflection of compatible ultrasound catheters inserted into the right atrium
2016-05-02
Cardiodrive System - The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.
2016-08-01
Niobe Cover Drape - Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Navigation Workstation. The Niobe MNS with Navigant NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction
2016-08-01
Niobe MNS Siemens - Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Navigation Workstation. The Niobe MNS with Navigant NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction
2016-08-01
Niobe MNS Philips - Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Navigation Workstation. The Niobe MNS with Navigant NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction
2016-08-01
Odyssey Enterprise Interface - The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab
2016-08-01
Odyssey Cinema - The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab
2016-08-01
Odyssey - The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab
2016-08-01
Vdrive Drape - """The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during theperformance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system, • Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance ofelectrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and • Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when usedin conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic NavigationSystem (MNS). """
2016-08-01
Navigant - The Navigant Navigation Workstation (NWS) is a component of the Magnetic Navigation System (MNS). The MNS with NWS 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 feature provides an enhanced navigation interface for the physician to control the MNS.
2022-06-06
Navigant - The Navigant Navigation Workstation (NWS) is a component of the Magnetic Navigation System (MNS). The MNS with NWS 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 feature provides an enhanced navigation interface for the physician to control the MNS.
2023-04-25
Hemostasis Adapter - Hemostasis Adapter IV Spares, Box, Device Count(5)
2021-12-14