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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
Original Applicant
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
veenpluis 4-6
best,  NL 5684 pc
Original 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
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