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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 K052461
Device Name SYNGO IMAGING VERSION V20A
Applicant
SIEMENS AG, MEDICAL SOLUTIONS
HENKESTRASSE 127
ERLANGEN,  DE 91052
Applicant Contact EVA-MARIA REITER
Correspondent
TUV AMERICA, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/08/2005
Decision Date 09/22/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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