Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System

FDA 510(k) K193147 · Stereotaxis, Inc.

Substantially Equivalent

510(k) numberK193147

Submission

Device name
Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System
Applicant
Stereotaxis, Inc.
St. Louis, MO, US
Received
November 13, 2019
Decision date
March 5, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PJB – Catheter Remote Control System
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5700
Specialty
Cardiovascular

A steerable cardiac ablation catheter remote control system is a device that is external to the body and interacts with the manual handle of a steerable cardiac ablation catheter to remotely control the advancement, retraction, rotation, and deflection of a steerable ablation catheter used for the treatment of cardiac arrhythmias in the right side of the heart. The device allows reversion to…

Other 510(k)s with product code PJB

510(k)DeviceApplicantDecision
K192775Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriPJB · Special Stereotaxis, Inc.10/30/2019SE
K183027Steerable catheter control systemPJB · Traditional Stereotaxis, Inc.09/06/2019SE

More from Stereotaxis, Inc.

510(k)DeviceDecision
K262744GenesisX RMNDXX · Special 08/27/2026SE
K253473SynchronyDQK · Traditional 04/01/2026SE
K251792Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)DXX · Traditional 11/06/2025SE
K250590MAGiC Sweep™ EP Mapping CatheterDRF · Traditional 07/23/2025SE
K192775Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriPJB · Special 10/30/2019SE
K183027Steerable catheter control systemPJB · Traditional 09/06/2019SE
K150312Vdrive system, Vdrive Duo, Vdrive with V-SonoDXX · Traditional 06/17/2015SE
K141530Vdrive System/ Vdrive Duo/ Vdrive with V-CasDXX · Traditional 12/18/2014SE
K140804Vdrive with V-Loop/ Vdrive DuoDXX · Traditional 09/03/2014SE
K133396Vdrive with V-SonoDQX · Special 02/06/2014SE

Questions and answers

When was Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System cleared by the FDA?

Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System (K193147) received a 510(k) decision of Substantially Equivalent on March 5, 2020, 113 days after the submission was received.

What is the product code of K193147?

The FDA product code is PJB – Catheter Remote Control System, a Class II (moderate risk) device regulated under 21 CFR 870.5700.