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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 K121772
Device Name ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best Noord-Brabant,  NL 5684 pc
Applicant Contact FRANS JACOBS
Correspondent
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best Noord-Brabant,  NL 5684 pc
Correspondent Contact FRANS JACOBS
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAK   LLZ  
Date Received06/15/2012
Decision Date 03/21/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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