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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 K061372
Device Name CENTRICITY AW SUITE OPTION
Applicant
GE HEALTHCARE INFORMATION TECHNOLOGIES
540 W. NW HIGHWAY
BARRINGTON,  IL  60010
Applicant Contact RHODA VALERA
Correspondent
UNDERWRITERS LABORATORIES, INC.
455 E. TRIMBLE ROAD
SAN JOSE,  CA  95131 -1230
Correspondent Contact ELIZABETH DREW
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/17/2006
Decision Date 05/30/2006
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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