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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 K193306
Device Name PROView
Applicant
Ge Medical Systems Scs
3000 N. Grandview Blvd.-Hq
Waukesha,  WI  53188 -1696
Applicant Contact Hong Cui
Correspondent
Ge Medical Systems Scs
3000 N. Grandview Blvd.-Hq
Waukesha,  WI  53188 -1696
Correspondent Contact Hong Cui
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/29/2019
Decision Date 11/17/2020
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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