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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K070796
Device Name CHILI PACS
Applicant
Chili GmbH
Burgstrasse 61
Heidelberg, Bw,  DE 69121
Applicant Contact UWE ENGELMANN
Correspondent
Tuv Sud America, Inc.
1775 Old Highway 8 NW
New Brighton,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/23/2007
Decision Date 04/06/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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