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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 K033326
Device Name PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
Applicant
PHILIPS MEDICAL SYSTEMS, INC.
595 miner rd.
highland hgts.,  OH  44143
Applicant Contact robert l turocy
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 commerce rd.
newton,  CT  06470
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/16/2003
Decision Date 10/29/2003
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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