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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 K093612
Device Name SYNGO.PLAZA
Applicant
Siemens AG Medical Solutions
Henkestrasse 127
Erlangen,  DE 91052
Correspondent
Tuv Sud America, Inc.
1775 Old Hwy. 8 NW
New Brighton,  MN  55112
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/23/2009
Decision Date 03/04/2010
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
Recalls CDRH Recalls
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