K251792

Substantially Equivalent

Stereotaxis GenesisX RMN with Navigant Workstation (NWS)

Applicant: Stereotaxis, Inc.
Product code: DXX
Advisory panel: Cardiovascular
Date received: 2025-06-11
Decision date: 2025-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint Louis, MO, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.