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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 K232910
Device Name CombiDiagnost R90
Applicant
Philips Medical Systems Dmc GmbH
Röntgenstrasse 24
Hamburg,  DE 22335
Applicant Contact Ming Xiao
Correspondent
Philips Medical Systems Dmc GmbH
Röntgenstrasse 24
Hamburg,  DE 22335
Correspondent Contact Ming Xiao
Regulation Number892.1650
Classification Product Code
JAA  
Subsequent Product Code
KPR  
Date Received09/19/2023
Decision Date 10/19/2023
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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