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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 K192065
Device Name Syngo.Via RT Image Suite
Applicant
Siemens Medical Solutions USA, Inc.
2501 N Barrington Rd.
Hoffman Estates,  IL  60192
Applicant Contact Veronica Padharia
Correspondent
Siemens Medical Solutions USA, Inc.
2501 N Barrington Rd.
Hoffman Estates,  IL  60192
Correspondent Contact Veronica Padharia
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received08/01/2019
Decision Date 09/18/2019
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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