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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 K042525
Device Name CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
800 BUSINESS CENTER DR.
MOUNT PROSPECT,  IL  60056
Applicant Contact CAROL ALLOIAN
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact CHANTEL CARSON
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/17/2004
Decision Date 10/01/2004
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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