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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
Applicant
MARCONI MEDICAL SYSTEMS, INC.
595 MINER RD.
HIGHLAND HEIGHTS,  OH  44143
Applicant Contact ROBERT L TUROCY
Correspondent
MARCONI MEDICAL SYSTEMS, INC.
595 MINER RD.
HIGHLAND HEIGHTS,  OH  44143
Correspondent Contact ROBERT L TUROCY
Regulation Number892.1750
Classification Product Code
JAK  
Date Received06/27/2001
Decision Date 09/13/2001
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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