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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 K043415
Device Name CENTRICITY PACS SYSTEM
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
800 BUSINESS CENTER DR.
MOUNT PROSPECT,  IL  60056
Applicant Contact CAROL ALLOIAN
Correspondent
UNDERWRITERS LABORATORIES, INC.
2600 NW LAKE RD.
CAMAS,  WA  98607 -9526
Correspondent Contact MARC M MOUSER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/13/2004
Decision Date 01/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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