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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 K181830
Device Name Azurion R2.0
Applicant
Philips Medical Systems Nederland BV
Veenpluis 4-6
Best,  NL 5684PC
Applicant Contact Owen Callaghan
Correspondent
Philips Medical Systems Nederland BV
Veenpluis 4-6
Best,  NL 5684PC
Correspondent Contact Owen Callaghan
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received07/09/2018
Decision Date 08/02/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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