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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 K133654
Device Name SCENIUM
Applicant
Siemens Medical Solutions USA, Inc.
2501 N. Barrington Rd.
Hoffman Estates,  IL  60192
Applicant Contact MARIA EBIO
Correspondent
Siemens Medical Solutions USA, Inc.
2501 N. Barrington Rd.
Hoffman Estates,  IL  60192
Correspondent Contact MARIA EBIO
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
KPS  
Date Received11/27/2013
Decision Date 02/28/2014
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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