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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lung Computed Tomography System, Computer-Aided Detection
510(k) Number K033412
Device Name MEDICLUNG, RELEASE 1
Applicant
Medicsight
46 Berkeley Sq.
London,  GB W1J 5AT
Applicant Contact CAROL MACDONALD
Correspondent
Medicsight
46 Berkeley Sq.
London,  GB W1J 5AT
Correspondent Contact CAROL MACDONALD
Regulation Number892.2050
Classification Product Code
OEB  
Date Received10/27/2003
Decision Date 12/30/2003
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
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