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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 K163715
Device Name Allura Xper R9
Applicant
PHILIPS MEDICAL SYSTEMS NEDERLAND BV
VEENPLUIS 4-6
BEST,  NL 5684 PC
Applicant Contact JEANETTE BECKER
Correspondent
PHILIPS MEDICAL SYSTEMS NEDERLAND BV
VEENPLUIS 4-6
BEST,  NL 5684 PC
Correspondent Contact JEANETTE BECKER
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received12/30/2016
Decision Date 01/26/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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