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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, stationary
510(k) Number K141381
Device Name DURADIAGNOST
Applicant
PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
NO. 258, ZHONG YUAN RD.
SUZHOU INDUSTRIAL PARK
JIANGSU,  CN 215024
Applicant Contact GORDON SHU
Correspondent
DEKRA CERTIFICATION B.V.
MEANDER 1051
ARNHEM,  NL NL-6825 MJ
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received05/27/2014
Decision Date 06/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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