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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K222428
Device Name Syngo Dynamics (Version VA40F)
Applicant
Siemens Medical Solutions USA, Inc.
400 W. Morgan Road
Ann Arbor,  MI  48108
Applicant Contact Jiayan Liu
Correspondent
Siemens Medical Solutions USA, Inc.
400 W. Morgan Road
Ann Arbor,  MI  48108
Correspondent Contact Jiayan Liu
Regulation Number892.2050
Classification Product Code
QIH  
Date Received08/11/2022
Decision Date 11/14/2022
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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