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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 K042605
Device Name COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
Applicant
Siemens AG Medical Solutions
Henkestrasse 127
Erlangen,  DE 91052
Applicant Contact RUDIGER KORNER
Correspondent
Tuv America, Inc.
1775 Old Highway 8
New Brighton,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number892.2050
Classification Product Code
NWE  
Date Received09/24/2004
Decision Date 10/08/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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