AI Segmentation

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 Ai Segmentation.

Pre-market Notification Details

Device IDK211881
510k NumberK211881
Device Name:AI Segmentation
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto,  CA  94304
ContactPeter Coronado
CorrespondentPeter Coronado
Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto,  CA  94304
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-21
Decision Date2021-09-02

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