Niobe MNS Omega

Primary DI: M58800100620010
Brand: Niobe MNS Omega
Company: Stereotaxis, Inc.
Model: ES Omega
Catalog number: 001-006200-1
Device description: 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.
Published: 2026-04-23
Public version status: New
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true

Contact Domains#

Code, Name table
Code	Name
NDQ	System, Catheter Or Guidewire, Steerable (Magnetic)

Code, Device, Specialty table
Code	Device	Specialty	Class
NDQ	System, Catheter Or Guidewire, Steerable (Magnetic)	Cardiovascular	2

Submission, Supplement table
Submission	Supplement
K192775	000

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K192775	000	Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri	Stereotaxis, Inc.	2019-10-30	PJB

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
M58800100620010	Primary	HIBCC	0

Term, Definition table
Term	Definition
Cardiac mapping system workstation	A mains electricity (AC-powered) device designed as a control unit to percutaneously navigate (orientate and steer) a cardiac mapping system catheter, or its associated guidewire, in the desired direction to the designated target site (e.g., coronary vasculature). It uses dedicated software and may employ various technologies (often magnetic fields); it is typically used in the electrophysiology (EP) laboratory.

Phone, Email table
Phone	Email
13146756100	info@stereotaxis.com

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
M58800101400010	GenesisX	1	0010140001	2026-01-09
M588001004115110	Cardiodrive System	II	001-004115-11	2022-06-06
M588001004115120	Cardiodrive System	II	001-004115-12	2022-06-06
M58800101100010	Genesis (RMNS)	1.1	001-011000-1	2020-08-20
M58800101100030	Genesis MNS with Model-S	1.1 Model-S	001-011000-3	2020-08-20
M588020004500210	Navigant	4.6.4	020-004500-21	2016-08-01
M588020004500220	Navigant	4.6.5	020-004500-22	2016-08-01
M588020004500260	Navigant	5.0.2	020-004500-26	2016-10-27
M58800100701020	Odyssey	Quad HD	001-007010-2	2016-08-01
M58800100111411	Hemostasis Adapter	IV-1	0010011141	2021-12-14
M58802000780030	Cinema MAS & MMS	DMS-100	020-007800-3	2016-08-01
M58800100175110	QuikCAS Cardiodrive Sterile Components	1	001-001751-1	2016-05-02
M5880010017711	QuikCAS Hemostasis Adapter	1	001-001771-1	2016-08-01
M5880010017712	Cardiodrive Hemostasis Adapter - SJ	1	001-001771-2	2016-08-01
M58800100230710	Vdrive System	Single Arm	001-002307-1	2016-08-01
M58800100230720	Vdrive System	Duo	001-002307-2	2016-08-01
M58800100242210	V-CAS Catheter Advancement System	1	001-002422-1	2016-05-02
M58800100245210	V-Loop Variable Loop Catheter Manipulator	1	001-002452-1	2016-05-02
M58800100246910	V-Sono Intracardiac Echo Manipulator	1	001-002469-1	2016-05-02
M58800100411590	Cardiodrive System	II	001-004115-9	2016-08-01

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
M588020004500370	Navigant	Stereotaxis, Inc.	NDQ	2023-04-25
M588020004500360	Navigant	Stereotaxis, Inc.	NDQ	2022-06-06
M58800101100010	Genesis (RMNS)	Stereotaxis, Inc.	NDQ	2020-08-20
M58800101100030	Genesis MNS with Model-S	Stereotaxis, Inc.	NDQ	2020-08-20
M588020004500260	Navigant	Stereotaxis, Inc.	NDQ	2016-10-27
M58800100591011	Niobe Cover Drape	Stereotaxis, Inc.	NDQ	2016-08-01
M58800100600010	Niobe MNS Siemens	Stereotaxis, Inc.	NDQ	2016-08-01
M58800100610010	Niobe MNS Philips	Stereotaxis, Inc.	NDQ	2016-08-01
M588020004500210	Navigant	Stereotaxis, Inc.	NDQ	2016-08-01
M588020004500220	Navigant	Stereotaxis, Inc.	NDQ	2016-08-01