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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 K091195
Device Name PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511
Applicant
Philips Medical Systems (Cleveland), Inc.
595 Miner Rd.
Cleveland,  OH  44143
Applicant Contact MICHAEL CHILBERT
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact NED DIVINE
Regulation Number892.1750
Classification Product Code
JAK  
Date Received04/23/2009
Decision Date 05/27/2009
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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