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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 K063628
Device Name CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY
Applicant
Ge Healthcare Integrated IT Solutions
540 W. NW Highway
Barrington,  IL  60010
Applicant Contact KAREN M LUNDE
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact SILVIA ANKOVA
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/06/2006
Decision Date 12/26/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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