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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 North Grandview Boulevard-HQ
Waukesha,  WI  53188 -1696
Applicant Contact Hong Cui
Correspondent
GE Medical Systems SCS
3000 North Grandview Boulevard-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
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