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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 K172822
Device Name Azurion series R1.2
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best Noord-Brabant,  NL 5684 pc
Applicant Contact Jeanette Becker
Correspondent
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best Noord-Brabant,  NL 5684 pc
Correspondent Contact Jeanette Becker
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received09/18/2017
Decision Date 11/22/2017
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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