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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 K033357
Device Name ACQSIM-MULTISLICE-CT, MODEL 453567042271
Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 MINER ROAD
HIGHLAND HTS.,  OH  44143
Applicant Contact ROBERT B SMITH
Correspondent
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 MINER ROAD
HIGHLAND HTS.,  OH  44143
Correspondent Contact ROBERT B SMITH
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/20/2003
Decision Date 01/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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