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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 K171850
Device Name Philips CT Big Bore
Applicant
Philips Medical Systems (Cleveland) Inc.
595 Miner Road
Cleveland,  OH  44143
Applicant Contact Michael Chilbert
Correspondent
Philips Medical Systems (Cleveland) Inc.
595 Miner Road
Cleveland,  OH  44143
Correspondent Contact Michael Chilbert
Regulation Number892.1750
Classification Product Code
JAK  
Date Received06/21/2017
Decision Date 11/09/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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