Eclipse Treatment Planning System V16.1

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 Eclipse Treatment Planning System V16.1.

Pre-market Notification Details

Device IDK201607
510k NumberK201607
Device Name:Eclipse Treatment Planning System V16.1
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant Varian Medical Systems, Inc 911 Hansen Way Palo Alto,  CA  94304
ContactPeter J. Coronado
CorrespondentPeter J. Coronado
Varian Medical Systems, Inc 911 Hansen Way Palo Alto,  CA  94304
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-15
Decision Date2020-07-10

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.