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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 K191761
Device Name Mobius3D
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
IYE  
Date Received07/01/2019
Decision Date 07/31/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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