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FDA 510(k)

NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05

K-Number: K051760 · 2006-05-05

ApplicantStereotaxis, Inc.
Decision Date2006-05-05
Product CodeDXX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05 is the device name listed in this FDA 510(k) record. The listed applicant is Stereotaxis, Inc.. It received FDA 510(k) clearance on 2006-05-05 under 510(k) number K051760. The device is classified under product code DXX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05?

NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05 is a medical device that received FDA 510(k) clearance on 2006-05-05. The listed applicant is Stereotaxis, Inc.. The 510(k) number is K051760.

When did NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05 receive FDA 510(k) clearance?

NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05 received FDA 510(k) clearance on 2006-05-05, under 510(k) number K051760.

Who is the listed applicant for NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05?

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 NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05?

The FDA product code for NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05 is DXX.

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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.

K262744GenesisX RMNK253473SynchronyK251792Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)K250590MAGiC Sweep™ EP Mapping CatheterK193147Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemK192775Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri

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Related Devices (Code: DXX)

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.

K262744GenesisX RMNStereotaxis, Inc.K251792Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)Stereotaxis, Inc.K243789LIBERTY Endovascular Robotic System (LIBERTYOS)Microbot Medical , Ltd.K221464CorPath GRX SystemCorindus, Inc.K202275CorPath GRX SystemCorindus, Inc.K180517CorPath GRX SystemCorindus, 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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