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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 K130638
Device Name ALLURACLARITY XPER FD SERIES X-RAY SYSTEM
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best,  NL 5694 PC
Applicant Contact KLIEN VAN DAM
Correspondent
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best,  NL 5694 PC
Correspondent Contact KLIEN VAN DAM
Regulation Number892.1650
Classification Product Code
OWB  
Date Received03/11/2013
Decision Date 06/28/2013
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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