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FDA 510(k)

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

K-Number: K193147 · 2020-03-05

ApplicantStereotaxis, Inc.
Decision Date2020-03-05
Product CodePJB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System is a medical device manufactured by Stereotaxis, Inc.. It received FDA 510(k) clearance on 2020-03-05 under approval number K193147. The device is classified under product code PJB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System?

Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System is a medical device that received FDA 510(k) clearance on 2020-03-05. It is manufactured by Stereotaxis, Inc.. The 510(k) number is K193147.

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

Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System received FDA 510(k) clearance on 2020-03-05, under approval number K193147.

What company makes Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System?

Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System is manufactured by Stereotaxis, Inc..

What is the FDA product code for Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System?

The FDA product code for Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System is PJB.

Related Clinical Trials

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Other Devices by Stereotaxis, Inc.

K192775Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri K183027Steerable catheter control system K251792Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) K250590MAGiC Sweep™ EP Mapping Catheter K253473Synchrony PMA P240014Cardiac ablation percutaneous catheter

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Related Devices (Code: PJB)

K192775Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriStereotaxis, Inc. K183027Steerable catheter control systemStereotaxis, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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