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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Catheter Control, Steerable
510(k) Number K251792
Device Name Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)
Applicant
Stereotaxis, Inc.
710 Tucker Blvd.
Suite 110
Saint Louis,  MO  63101
Applicant Contact Angela McKnight
Correspondent
Stereotaxis, Inc.
710 Tucker Blvd.
Suite 110
Saint Louis,  MO  63101
Correspondent Contact Angela McKnight
Regulation Number870.1290
Classification Product Code
DXX  
Date Received06/11/2025
Decision Date 11/06/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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