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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 K201062
Device Name syngo Ultrasound Apps Suite (sUSAS)
Applicant
Siemens Medical Solutions, USA, Inc.
685 East Middlefield Road
Mountain View,  CA  94043
Applicant Contact Christine Dunbar
Correspondent
Siemens Medical Solutions, USA, Inc.
685 East Middlefield Road
Mountain View,  CA  94043
Correspondent Contact Christine Dunbar
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/21/2020
Decision Date 05/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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