FDA.reportPublic FDA data

Navigant

Primary DI
M588020004500380
Brand
Navigant
Company
Stereotaxis, Inc.
Model
5.2
Catalog number
020-004500-38
Device description
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.
Published
2026-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDQSystem, Catheter Or Guidewire, Steerable (Magnetic)
PJBCatheter Remote Control System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDQSystem, Catheter Or Guidewire, Steerable (Magnetic)Cardiovascular2
PJBCatheter Remote Control SystemCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193147000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193147000Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemStereotaxis, Inc.2020-03-05PJB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M588020004500380PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical navigation system application softwareAn individual application software program or group of programs, routines and/or algorithms designed for use in association with a robotic surgical navigation system used in computer assisted surgery (CAS) so that this can function according to its intended purpose. This program can be permanently installed or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.

Contacts#

Phone, Email table
PhoneEmail
13146786100info@stereotaxis.com

Regulatory Flags#

DUNS number
024942265
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M58800100620010Niobe MNS OmegaES Omega001-006200-12026-04-23
M58800101400010GenesisX100101400012026-01-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M58800100620010Niobe MNS OmegaStereotaxis, Inc.NDQ2026-04-23
M588020004500370NavigantStereotaxis, Inc.PJB2023-04-25
M588020004500370NavigantStereotaxis, Inc.NDQ2023-04-25
M588020004500360NavigantStereotaxis, Inc.NDQ2022-06-06
M58800101100010Genesis (RMNS) Stereotaxis, Inc.NDQ2020-08-20
M58800101100010Genesis (RMNS) Stereotaxis, Inc.PJB2020-08-20
M58800101100030Genesis MNS with Model-SStereotaxis, Inc.NDQ2020-08-20
M58800101100030Genesis MNS with Model-SStereotaxis, Inc.PJB2020-08-20
M588020004500260NavigantStereotaxis, Inc.NDQ2016-10-27
M58800100591011Niobe Cover DrapeStereotaxis, Inc.NDQ2016-08-01
M58800100600010Niobe MNS SiemensStereotaxis, Inc.NDQ2016-08-01
M58800100610010Niobe MNS PhilipsStereotaxis, Inc.NDQ2016-08-01
M588020004500210NavigantStereotaxis, Inc.NDQ2016-08-01
M588020004500220NavigantStereotaxis, Inc.NDQ2016-08-01