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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 K150085
Device Name GE EchoPAC
Applicant
Ge Vingmed Ultrasound AS
Strandpromenaden 45
P.O. Box 141
Horten,  NO 3191
Applicant Contact Bryan Behn
Correspondent
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
9900 W Innovation Dr., Rp-2138
Wauwatosa,  WI  53226
Correspondent Contact Bryan Behn
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/15/2015
Decision Date 03/02/2015
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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