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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 K201195
Device Name syngo.via MI Workflows, syngo MBF
Applicant
Siemens Medical Solutions USA, Inc.
2501 N. Barrington Road
Hoffman Estates,  IL  60192
Applicant Contact Clayton Ginn
Correspondent
Siemens Medical Solutions USA, Inc.
2501 N. Barrington Road
Hoffman Estates,  IL  60192
Correspondent Contact Clayton Ginn
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received05/04/2020
Decision Date 11/18/2020
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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