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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K170847
Device Name EchoPAC Software Only, EchoPAC Plug-in
Applicant
GE Medical Systems Ultrasound and Primary Care Diagnostics
9900 Innovation Drive
Wauwatosa,  WI  53226
Applicant Contact Renee Webb
Correspondent
GE Medical Systems Ultrasound and Primary Care Diagnostics
9900 Innovation Drive
Wauwatosa,  WI  53226
Correspondent Contact Renee Webb
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/20/2017
Decision Date 06/14/2017
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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