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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 K083327
Device Name SYNGOCIRCULATION DYNAMICPET, VERSION 1.0
Applicant
Siemens Medical Solutions USA, Inc.
2501 N. Barrington Rd.
Hoffman Estates,  IL  60192
Applicant Contact GUNHILD PAULSEN
Correspondent
Siemens Medical Solutions USA, Inc.
2501 N. Barrington Rd.
Hoffman Estates,  IL  60192
Correspondent Contact GUNHILD PAULSEN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/12/2008
Decision Date 05/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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