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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K232799
Device Name syngo.via RT Image Suite
Applicant
Siemens Medical Solutions USA, Inc.
810 Innovation Drive
Knoxville,  TN  37932
Applicant Contact Monsuru Bello
Correspondent
Siemens Medical Solutions USA, Inc.
810 Innovation Drive
Knoxville,  TN  37932
Correspondent Contact Monsuru Bello
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received09/12/2023
Decision Date 04/26/2024
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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