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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 the device name listed in this FDA 510(k) record. The listed applicant is Stereotaxis, Inc.. It received FDA 510(k) clearance on 2020-03-05 under 510(k) 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. The listed applicant is Stereotaxis, Inc.. The 510(k) number is K193147.

When did Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System receive FDA 510(k) clearance?

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

Who is the listed applicant for Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System?

The FDA 510(k) record lists Stereotaxis, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Stereotaxis, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P240014Cardiac ablation percutaneous catheterK253473SynchronyK251792Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)K250590MAGiC Sweep™ EP Mapping CatheterK192775Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriK183027Steerable catheter control system

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Related Devices (Code: PJB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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