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 a medical device manufactured by Stereotaxis, Inc.. It received FDA 510(k) clearance on 2025-11-06 under approval 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. It is manufactured by Stereotaxis, Inc.. The 510(k) number is K251792.
When was Stereotaxis GenesisX RMN with Navigant Workstation (NWS) approved by the FDA?
Stereotaxis GenesisX RMN with Navigant Workstation (NWS) received FDA 510(k) clearance on 2025-11-06, under approval number K251792.
What company makes Stereotaxis GenesisX RMN with Navigant Workstation (NWS)?
Stereotaxis GenesisX RMN with Navigant Workstation (NWS) is manufactured by Stereotaxis, Inc..
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.
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Related Devices (Code: DXX)
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.