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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 K230557
Device Name Eclipse Treatment Planning System (v18.0)
Applicant
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto,  CA  94304
Applicant Contact Peter J. Coronado
Correspondent
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto,  CA  94304
Correspondent Contact Peter J. Coronado
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received02/28/2023
Decision Date 05/26/2023
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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