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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 K201640
Device Name DuraDiagnost
Applicant
Philips Healthcare (Suzhou) Co., Ltd.
# 258, Zhongyuan Rd., Suzhou Industrial Park,
Suzhou,  CN 215024
Applicant Contact Mary Zhu
Correspondent
Philips Healthcare (Suzhou) Co., Ltd.
# 258, Zhongyuan Rd., Suzhou Industrial Park,
Suzhou,  CN 215024
Correspondent Contact Mary Zhu
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received06/16/2020
Decision Date 07/09/2020
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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