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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 K203469
Device Name AI Segmentation
Applicant
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto,  CA  94304
Applicant Contact Peter Coronado
Correspondent
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto,  CA  94304
Correspondent Contact Peter Coronado
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received11/25/2020
Decision Date 04/19/2021
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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