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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 K203677
Device Name ViewPoint 6
Applicant
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
9900 W Innovation Dr.
Wauwatosa,  WI  53226
Applicant Contact Tracey Ortiz
Correspondent
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
9900 W Innovation Dr.
Wauwatosa,  WI  53226
Correspondent Contact Tracey Ortiz
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/17/2020
Decision Date 01/15/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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