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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 K163711
Device Name IQon Spectral CT
Applicant
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland,  OH  44143
Applicant Contact Steven Goldberg
Correspondent
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland,  OH  44143
Correspondent Contact Steven Goldberg
Regulation Number892.1750
Classification Product Code
JAK  
Date Received12/30/2016
Decision Date 04/05/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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