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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 K083423
Device Name COLONCAD API 3.1
Applicant
MEDICSIGHT PLC
66 HAMMERSMITH ROAD
LONDON,  GB W148UD
Applicant Contact AMARJIT GILL
Correspondent
MEDICSIGHT PLC
66 HAMMERSMITH ROAD
LONDON,  GB W148UD
Correspondent Contact AMARJIT GILL
Regulation Number892.2050
Classification Product Code
NWE  
Date Received11/19/2008
Decision Date 05/17/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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