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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
Recalls CDRH Recalls
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