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510(k) K251792

Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) by Stereotaxis, Inc. — Product Code DXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2025
Date Received
June 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Catheter Control, Steerable
Device Class
Class II
Regulation Number
870.1290
Review Panel
CV
Submission Type

Other clearances by Stereotaxis, Inc.

  • K250590 — MAGiC Sweep™ EP Mapping Catheter (July 23, 2025)
  • K193147 — Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System (March 5, 2020)
  • K192775 — Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Card (October 30, 2019)
  • K183027 — Steerable catheter control system (September 6, 2019)
  • K150312 — Vdrive system, Vdrive Duo, Vdrive with V-Sono (June 17, 2015)
  • K141530 — VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS (December 18, 2014)
  • K140804 — VDRIVE WITH V-LOOP/ VDRIVE DUO (September 3, 2014)
  • K133396 — VDRIVE WITH V-SONO (February 6, 2014)
  • K122659 — VDRIVE W/V-SONO (July 26, 2013)
  • K093092 — ODYSSEY WORKSTATION (January 21, 2010)

Other clearances for product code DXX

  • K243789 — LIBERTY Endovascular Robotic System (LIBERTYOS) (September 4, 2025)
  • K221464 — CorPath GRX System (July 27, 2022)
  • K202275 — CorPath GRX System (December 11, 2020)
  • K180517 — CorPath GRX System (March 29, 2018)
  • K173806 — CorPath GRX System (March 1, 2018)
  • K173288 — CorPath GRX System (February 15, 2018)
  • K160121 — CorPath GRX System (October 27, 2016)
  • K152999 — CorPath 200 System (March 18, 2016)
  • K150892 — CorPath 200 System (October 2, 2015)
  • K151730 — Magellan Robotic System (July 23, 2015)