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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 K162370
Device Name syngo.via RT Image Suite
Applicant
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd., Mail Code 65-1A
Malvern,  PA  19355
Applicant Contact Kimberly Mangum
Correspondent
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd., Mail Code 65-1A
Malvern,  PA  19355
Correspondent Contact Kimberly Mangum
Regulation Number892.5050
Classification Product Code
MUJ  
Subsequent Product Code
LLZ  
Date Received08/24/2016
Decision Date 10/25/2016
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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