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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K173433
Device Name ProxiDiagnost N90
Applicant
Philips Medical Systems Dmc GmbH
Roentgenstrasse 24-26
Hamburg,  DE 22335
Applicant Contact Ming Xiao
Correspondent
Philips Medical Systems Dmc GmbH
Roentgenstrasse 24-26
Hamburg,  DE 22335
Correspondent Contact Ming Xiao
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received11/02/2017
Decision Date 02/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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