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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
Recalls CDRH Recalls
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