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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 K170747
Device Name syngo Application Software
Applicant
Siemens Medical Solutions, USA, Inc.
40 Liberty Boulevard 65-1A
Malvern,  PA  19355
Applicant Contact Patricia D. Jones
Correspondent
Siemens Medical Solutions, USA, Inc.
40 Liberty Boulevard 65-1A
Malvern,  PA  19355
Correspondent Contact Patricia D. Jones
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/10/2017
Decision Date 06/09/2017
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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