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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K202564
Device Name DigitalDiagnost C90
Applicant
Philips Medical Systems DMC GmbH
Röntgenstraße 24
Hamburg,  DE 22335
Applicant Contact Ming Xiao
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number892.1680
Classification Product Code
MQB  
Subsequent Product Codes
KPR   LLZ  
Date Received09/04/2020
Decision Date 09/30/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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