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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 K123174
Device Name CENTRICITY PACS-IW WITH UNIVERSAL VIEWER
Applicant
Ge Healthcare
540 W Northwest Highway
Barrington,  IL  60010
Applicant Contact CHERYL BORK
Correspondent
Ge Healthcare
540 W Northwest Highway
Barrington,  IL  60010
Correspondent Contact CHERYL BORK
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/10/2012
Decision Date 11/16/2012
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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