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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 K023557
Device Name CENTRICITY PACS PLUS
Applicant
GE MEDICAL SYSTEMS
800 E. BUSINESS CENTER DR.
MOUNT PROSPECT,  IL  60056
Applicant Contact SCOTT EVANS
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
1279 QUARRY LANE, SUITE A
PLEASANTON,  CA  94566
Correspondent Contact HEINZ J STENEBERG
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/23/2002
Decision Date 11/07/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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