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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 K113483
Device Name ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION
Applicant
PHILIPS HEALTHCARE (CLEVELAND)
595 MINER RD.
CLEVELAND,  OH  44143
Applicant Contact CHRISTINE ANDERSON
Correspondent
PHILIPS HEALTHCARE (CLEVELAND)
595 MINER RD.
CLEVELAND,  OH  44143
Correspondent Contact CHRISTINE ANDERSON
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/23/2011
Decision Date 09/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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