4D Integrated Treatment Console

System, Planning, Radiation Therapy Treatment

Varian Medical Systems, Inc.

The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for 4d Integrated Treatment Console.

Pre-market Notification Details

Device IDK203766
510k NumberK203766
Device Name:4D Integrated Treatment Console
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto,  CA  94304
ContactPeter J. Coronado
CorrespondentPeter J. Coronado
Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto,  CA  94304
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-23
Decision Date2021-02-12

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