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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K132524
Device Name CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION
Applicant
PHILIPS MEDICAL SYSTEMS
595 MINER ROAD
CLEVELAND,  OH  44143
Applicant Contact SUSAN QUICK
Correspondent
PHILIPS MEDICAL SYSTEMS
595 MINER ROAD
CLEVELAND,  OH  44143
Correspondent Contact SUSAN QUICK
Regulation Number892.1750
Classification Product Code
JAK  
Date Received08/12/2013
Decision Date 06/13/2014
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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