GenesisX 0010140001

GUDID M58800101400010

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.

Stereotaxis, Inc.

Robotic surgical navigation system
Primary Device IDM58800101400010
NIH Device Record Keye40f3e15-e4dd-4e8f-99e2-5a0eb3b16e4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameGenesisX
Version Model Number1
Catalog Number0010140001
Company DUNS024942265
Company NameStereotaxis, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com
Phone13146786100
Emailinfo@stereotaxis.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM58800101400010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXXSystem, Catheter Control, Steerable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-19
Device Publish Date2026-01-09

Devices Manufactured by Stereotaxis, Inc.

M58800101400010 - GenesisX2026-01-19Stereotaxis 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.
M58800101400010 - GenesisX2026-01-19 Stereotaxis GenesisX RMN with Navigant™ Workstation (NWS) and Cardiodrive® System (GenesisX) is an interventional workstation
M58800100175110 - QuikCAS Cardiodrive Sterile Components2024-07-17 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E
M5880010017711 - QuikCAS Hemostasis Adapter2024-07-17 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E
M5880010017712 - Cardiodrive Hemostasis Adapter - SJ2024-07-17 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E
M58800100230710 - Vdrive System2024-07-17 "The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE
M58800100230720 - Vdrive System2024-07-17 "The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE
M58800100242210 - V-CAS Catheter Advancement System2024-07-17 The Vdrive with V-CAS Disposable is indicated for remotely controlling the advancement, retraction, and rotation of compatible m
M58800100245210 - V-Loop Variable Loop Catheter Manipulator2024-07-17 The Vdrive with V-Loop disposable is indicated to remotely control the advancement, retraction, rotation, tip deflection and loo

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