Genesis (RMNS)

Primary DI
M58800101100010
Brand
Genesis (RMNS)
Company
Stereotaxis, Inc.
Model
1.1
Catalog number
001-011000-1
Device description
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.
Published
2020-08-20
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
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
M58800101100010PrimaryHIBCC0

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
M58800101400010GenesisX100101400012026-01-09
M588001004115110Cardiodrive SystemII001-004115-112022-06-06
M588001004115120Cardiodrive SystemII001-004115-122022-06-06
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

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
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