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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 K201444
Device Name Syngo.via RT Image Suite
Applicant
Siemens Medical Solutions USA, Inc.
2501 N Barrington Rd.
Hoffman Estate,  IL  60192
Applicant Contact Cynthia Busch
Correspondent
Siemens Medical Solutions USA, Inc.
2501 N Barrington Rd.
Hoffman Estate,  IL  60192
Correspondent Contact Cynthia Busch
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received06/01/2020
Decision Date 08/13/2020
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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