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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, Fluoroscopic, Image-Intensified
510(k) Number K163210
Device Name Philips CombiDiagnost R90
Applicant
Philips Medical Systems DMC GmbH
Roentgenstrasse 24-26
Hamburg,  DE 22335
Applicant Contact Ming Xiao
Correspondent
Philips Medical Systems DMC GmbH
Roentgenstrasse 24-26
Hamburg,  DE 22335
Correspondent Contact Ming Xiao
Regulation Number892.1650
Classification Product Code
JAA  
Subsequent Product Codes
KPR   MQB  
Date Received11/15/2016
Decision Date 01/31/2017
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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