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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K170113
Device Name pixium 4343RCE
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 Number892.1680
Classification Product Code
MQB  
Date Received01/12/2017
Decision Date 02/09/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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