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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K131773
Device Name BRILLIANCE ICT
Applicant
Philips Healthcare (Cleveland)
595 Miner Rd.
Cleveland,  OH  44143
Applicant Contact CATHERINE M CONNELL
Correspondent
Philips Healthcare (Cleveland)
595 Miner Rd.
Cleveland,  OH  44143
Correspondent Contact CATHERINE M CONNELL
Regulation Number892.1750
Classification Product Code
JAK  
Date Received06/17/2013
Decision Date 09/24/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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