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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 K141979
Device Name ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES
Applicant
PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V.
VEENPLUIS 4-6
5684-PC
BEST,  NL NETHERLAND
Applicant Contact JEANETTE BECKER
Correspondent
PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V.
VEENPLUIS 4-6
5684-PC
BEST,  NL NETHERLAND
Correspondent Contact JEANETTE BECKER
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received07/21/2014
Decision Date 08/19/2014
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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