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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
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