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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 K010817
Device Name MX8000 V5.0 CT SYSTEM
Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 MINER RD.
CLEVELAND,  OH  44143
Applicant Contact ROBERT L TUROCY
Correspondent
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 MINER RD.
CLEVELAND,  OH  44143
Correspondent Contact ROBERT L TUROCY
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/19/2001
Decision Date 06/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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