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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 K220940
Device Name EchoPAC Software Only, EchoPAC Plug-in
Applicant
GE Medical Systems Ultrasound and Primary Care Diagnostics,
LLC
9900 W. Innovation Drive
Wauwatosa,  WI  53226
Applicant Contact Tracey Ortiz
Correspondent
GE Medical Systems Ultrasound and Primary Care Diagnostics,
LLC
9900 W. Innovation Drive
Wauwatosa,  WI  53226
Correspondent Contact Lee Bush
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received03/31/2022
Decision Date 07/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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