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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 K211379
Device Name syngo.via RT Image Suite
Applicant
Siemens Medical Solutions USA Inc.
810 Innovation Drive
Knoxville,  TN  37932
Applicant Contact Clayton Ginn
Correspondent
Siemens Medical Solutions USA Inc.
810 Innovation Drive
Knoxville,  TN  37932
Correspondent Contact Clayton Ginn
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received05/04/2021
Decision Date 07/30/2021
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
Recalls CDRH Recalls
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