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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K261623
Device Name EchoPAC Software Only / EchoPAC Plug-in (v211)
Applicant
GE Medical Systems Ultrasound and Primary Care Diagnostics
3200 N Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact Charlotte Joergensen
Correspondent
GE Medical Systems Ultrasound and Primary Care Diagnostics
3200 N Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact Charlotte Joergensen
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received05/15/2026
Decision Date 09/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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