GenesisX

Primary DI
M58800101400010
Brand
GenesisX
Company
Stereotaxis, Inc.
Model
1
Catalog number
0010140001
Device description
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.
Published
2026-01-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXXSystem, Catheter Control, Steerable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXXSystem, Catheter Control, SteerableCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251792000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251792000Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)Stereotaxis, Inc.2025-11-06DXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M58800101400010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical navigation systemAn assembly of electromechanical devices used during orthopaedic computer assisted surgery (CAS) as a functional extension of the surgeon for precise procedural movement and placement (navigation) during the procedure (e.g., placement of a pedicle screw in spinal surgery). It is computer-based and typically consists of, e.g., an operator's console and a video camera used to track the instrumentation. The input to the computer is usually by means of an existing CT or MRI scan that is used as a template. The system tracks the instrumentation by reading the location points giving a three-dimensional (3-D) picture of the instrument's position/angulation. It can also be used as a training aid.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
13146786100info@stereotaxis.com

Regulatory Flags#

DUNS number
024942265
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M58800100620010Niobe MNS OmegaES Omega001-006200-12026-04-23
M588001004115110Cardiodrive SystemII001-004115-112022-06-06
M588001004115120Cardiodrive SystemII001-004115-122022-06-06
M58800101100010Genesis (RMNS) 1.1001-011000-12020-08-20
M58800101100030Genesis MNS with Model-S1.1 Model-S001-011000-32020-08-20
M588020004500210Navigant4.6.4020-004500-212016-08-01
M588020004500220Navigant4.6.5020-004500-222016-08-01
M588020004500260Navigant5.0.2020-004500-262016-10-27
M58800100701020OdysseyQuad HD001-007010-22016-08-01
M58800100111411Hemostasis AdapterIV-100100111412021-12-14
M58802000780030Cinema MAS & MMSDMS-100020-007800-32016-08-01
M58800100175110QuikCAS Cardiodrive Sterile Components1001-001751-12016-05-02
M5880010017711QuikCAS Hemostasis Adapter1001-001771-12016-08-01
M5880010017712Cardiodrive Hemostasis Adapter - SJ1001-001771-22016-08-01
M58800100230710Vdrive SystemSingle Arm001-002307-12016-08-01
M58800100230720Vdrive SystemDuo001-002307-22016-08-01
M58800100242210V-CAS Catheter Advancement System1001-002422-12016-05-02
M58800100245210V-Loop Variable Loop Catheter Manipulator1001-002452-12016-05-02
M58800100246910V-Sono Intracardiac Echo Manipulator1001-002469-12016-05-02
M58800100411590Cardiodrive SystemII001-004115-92016-08-01

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