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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 K232000
Device Name syngo.via MI Workflows; Scenium; syngo MBF
Applicant
Siemens Medical Solutions USA, Inc.
2501 North Barrington Road
Hoffman Estates,  IL  60192
Applicant Contact Clayton Ginn
Correspondent
Siemens Medical Solutions USA, Inc.
2501 North Barrington Road
Hoffman Estates,  IL  60192
Correspondent Contact Clayton Ginn
Regulation Number892.2050
Classification Product Code
QIH  
Date Received07/05/2023
Decision Date 11/28/2023
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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