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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 K162859
Device Name Allura Xper FD series and Allura Xper OR Table series
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 Received10/12/2016
Decision Date 12/02/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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