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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accelerator, linear, medical
510(k) Number K171733
Device Name TrueBeam, TrueBeam STx, Edge
Applicant
Varian Medical Systems, Inc.
911 Hansen Way
Palo Alto,  CA  94304
Applicant Contact Sara Muddell
Correspondent
Varian Medical Systems, Inc.
911 Hansen Way
Palo Alto,  CA  94304
Correspondent Contact Sara Muddell
Regulation Number892.5050
Classification Product Code
IYE  
Date Received06/12/2017
Decision Date 07/12/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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