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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 K201725
Device Name DigitalDiagnost C50
Applicant
Philips Healthcare (Suzhou) Co., Lit.
No. 258, ZhongYuan Road
Suzhou Industrial Park
Suzhou,  CN 215024
Applicant Contact Claire Zhang
Correspondent
Philips Healthcare (Suzhou) Co., Lit.
No. 258, ZhongYuan Road
Suzhou Industrial Park
Suzhou,  CN 215024
Correspondent Contact Claire Zhang
Regulation Number892.1680
Classification Product Code
KPR  
Date Received06/23/2020
Decision Date 07/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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