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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K253473
Device Name Synchrony
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 Number870.1425
Classification Product Code
DQK  
Date Received10/10/2025
Decision Date 04/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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