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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 K192377
Device Name Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon
Applicant
Varian Medical Systems, Inc.
911 Hansen Way
palo alto,  CA  94304
Applicant Contact peter j coronado
Correspondent
Varian Medical Systems, Inc.
911 Hansen Way
palo alto,  CA  94304
Correspondent Contact peter j coronado
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
MUJ  
Date Received08/30/2019
Decision Date 02/10/2020
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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