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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 K253689
Device Name syngo Dynamics (VA41F)
Applicant
Siemens Healthcare GmbH
Henkestr. 127
Erlanger,  DE 91052
Applicant Contact Jiayan Liu
Correspondent
Siemens Healthcare GmbH
Henkestr. 127
Erlanger,  DE 91052
Correspondent Contact Jiayan Liu
Regulation Number892.2050
Classification Product Code
QIH  
Date Received11/21/2025
Decision Date 04/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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