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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 K100619
Device Name SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827
Applicant
Siemens Medical Solutions USA, Inc.
2501 N. Barrington Rd.
Hiffman Estates,  IL  60192
Applicant Contact ELAINE CHANG
Correspondent
Siemens Medical Solutions USA, Inc.
2501 N. Barrington Rd.
Hiffman Estates,  IL  60192
Correspondent Contact ELAINE CHANG
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/04/2010
Decision Date 05/07/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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