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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 K232923
Device Name Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)
Applicant
Varian Medical Systems Inc.
3100 Hansen Way
Palo Alto,  CA  94304
Applicant Contact Lynn Allman
Correspondent
Varian Medical Systems Inc.
3100 Hansen Way
Palo Alto,  CA  94304
Correspondent Contact Lynn Allman
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
MUJ  
Date Received09/19/2023
Decision Date 04/30/2024
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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