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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 K210692
Device Name DigitalDiagnost
Applicant
Philips Medical Systems Dmc GmbH
Roentgenstrasse 24-26
Hamburg,  DE 22335
Applicant Contact Supriya Dalvi
Correspondent
Philips Medical Systems Dmc GmbH
Roentgenstrasse 24-26
Hamburg,  DE 22335
Correspondent Contact Supriya Dalvi
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Codes
LLZ   MQB  
Date Received03/08/2021
Decision Date 04/02/2021
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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