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FDA 510(k)

Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)

K-Number: K251792 · 2025-11-06

ApplicantStereotaxis, Inc.
Decision Date2025-11-06
Product CodeDXX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) is the device name listed in this FDA 510(k) record. The listed applicant is Stereotaxis, Inc.. It received FDA 510(k) clearance on 2025-11-06 under 510(k) number K251792. 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 Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)?

Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) is a medical device that received FDA 510(k) clearance on 2025-11-06. The listed applicant is Stereotaxis, Inc.. The 510(k) number is K251792.

When did Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) receive FDA 510(k) clearance?

Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) received FDA 510(k) clearance on 2025-11-06, under 510(k) number K251792.

Who is the listed applicant for Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)?

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 GenesisX RMN with Navigant ™ Workstation (NWS)?

The FDA product code for Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) is DXX.

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.

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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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