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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
Original Applicant
595 miner rd.
cleveland,  OH  44143
Original Contact robert l turocy
Regulation Number892.1750
Classification Product Code
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