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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 K160743
Device Name Philips Ingenuity CT
Applicant
Philips Medical Systems (Cleveland), Inc.
595 Miner Rd
Cleveland,  OH  44143
Applicant Contact Susan Quick
Correspondent
Philips Medical Systems (Cleveland), Inc.
595 Miner Rd
Cleveland,  OH  44143
Correspondent Contact Susan Quick
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/17/2016
Decision Date 08/08/2016
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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