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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 K033374
Device Name LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
Applicant
Siemens AG Medical Solutions
Siemensstrasse 1
Forchheim,  DE D 91301
Applicant Contact RUDIGER KORNER
Correspondent
Tuv America, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Regulation Number892.2050
Classification Product Code
OEB  
Date Received10/22/2003
Decision Date 11/06/2003
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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