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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 K242463
Device Name ARIA Radiation Therapy Management System (18.1)
Applicant
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto,  CA  64304
Applicant Contact Dr. Lynn Allman
Correspondent
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto,  CA  64304
Correspondent Contact Dr. Lynn Allman
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received08/19/2024
Decision Date 12/13/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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