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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 K163410
Device Name DigitalDiagnost C50
Applicant
Philips Healthcare (Suzhou) Co., Ltd.
# 258, Zhongyuan Rd., Suzhou Industrial Park,
Suzhou,  CN 215024
Applicant Contact ALINA ZHOU
Correspondent
Philips Healthcare (Suzhou) Co., Ltd.
# 258, Zhongyuan Rd., Suzhou Industrial Park,
Suzhou,  CN 215024
Correspondent Contact ALINA ZHOU
Regulation Number892.1680
Classification Product Code
KPR  
Date Received12/05/2016
Decision Date 01/04/2017
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
Recalls CDRH Recalls
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