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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 K133674
Device Name PHILIPS IQON SPECTRAL CT
Applicant
PHILIPS HEALTHCARE (CLEVELAND)
595 MINER RD.
CLEVELAND,  OH  44143
Applicant Contact CATHERINE M CONNELL
Correspondent
PHILIPS HEALTHCARE (CLEVELAND)
595 MINER RD.
CLEVELAND,  OH  44143
Correspondent Contact CATHERINE M CONNELL
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/29/2013
Decision Date 11/21/2014
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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