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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 K012009
Device Name MX8000 IDT CT SYSTEM
Original Applicant
MARCONI MEDICAL SYSTEMS, INC.
595 miner rd.
highland heights,  OH  44143
Original Contact robert l turocy
Regulation Number892.1750
Classification Product Code
JAK  
Date Received06/27/2001
Decision Date 09/13/2001
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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