Stereotaxis GenesisX RMN with Navigant Workstation (NWS)— 510(k) K251792

Name: FDA 510(k) clearance K251792
Creator: U.S. Food and Drug Administration
Published: 2025-11-06

Substantially Equivalent

Stereotaxis, Inc.

FDA 510(k) clearance K251792 for Stereotaxis GenesisX RMN with Navigant Workstation (NWS), Substantially Equivalent on 2025-11-06. Applicant: Stereotaxis, Inc.. Device class: 2.

Clearance details

Applicant: Stereotaxis, Inc.
Product code: Code DXX
Device class: Class 2
Regulation: 21 CFR 870.1290
Advisory panel: Cardiovascular
Date received: 2025-06-11
Decision date: 2025-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint Louis, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DXX

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K262744 — GenesisX RMN2026-08-27
K243789 — LIBERTY Endovascular Robotic System (LIBERTYOS)2025-09-04
K221464 — CorPath GRX System2022-07-27
K202275 — CorPath GRX System2020-12-11
K180517 — CorPath GRX System2018-03-29

More clearances from Stereotaxis, Inc.

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K253473 — Synchrony2026-04-01
K250590 — MAGiC Sweep EP Mapping Catheter2025-07-23
K193147 — Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System2020-03-05
K192775 — Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri2019-10-30
K183027 — Steerable catheter control system2019-09-06

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