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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
510(k) Number K254161
Device Name Automated Aortic Stenosis Software (AutoAS)
Applicant
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
3200 N Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact Tahir Rizvi
Correspondent
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
3200 N Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact Tahir Rizvi
Regulation Number892.2060
Classification Product Code
POK  
Date Received12/22/2025
Decision Date 03/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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