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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 K200852
Device Name EchoPAC Software Only, EchoPAC Plug-In
Applicant
Ge Medical Systems Ultrasound and Primary Care Diagnostics
9900 Innovation Dr.
Wauwatosa,  WI  53226
Applicant Contact Tracey Ortiz
Correspondent
Ge Medical Systems Ultrasound and Primary Care Diagnostics
9900 Innovation Dr.
Wauwatosa,  WI  53226
Correspondent Contact Tracey Ortiz
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/31/2020
Decision Date 09/18/2020
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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