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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colon Computed Tomography System, Computer Aided Detection
510(k) Number K042674
Device Name COLON CAR 1.2
Applicant
MEDICSIGHT
46 BERKELEY SQUARE
LONDON,  GB W 1J 5AT
Applicant Contact CAROL MACDONALD
Correspondent
MEDICSIGHT
46 BERKELEY SQUARE
LONDON,  GB W 1J 5AT
Correspondent Contact CAROL MACDONALD
Regulation Number892.2050
Classification Product Code
NWE  
Date Received09/29/2004
Decision Date 10/19/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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