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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, Fluoroscopic, Image-Intensified
510(k) Number K203087
Device Name CombiDiagnost R90
Applicant
Philips Medical Systems DMC GmbH
Roentgenstrasse 24-26
Hamburg,  DE 22335
Applicant Contact Supriya Dalvi
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number892.1650
Classification Product Code
JAA  
Subsequent Product Codes
KPR   MQB  
Date Received10/13/2020
Decision Date 12/03/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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