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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 K253495
Device Name syngo.MR Applications (VB80)
Applicant
Siemens Healthineers AG
Siemensstraße 3
Forchheim,  DE 91301
Applicant Contact Vijay Ramadas
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
LNH  
Date Received10/28/2025
Decision Date 11/20/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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