Eclipse Treatment Planning System

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.

Pre-market Notification Details

Device IDK152393
510k NumberK152393
Device Name:Eclipse Treatment Planning System
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 Received2015-08-24
Decision Date2015-09-18
Summary:summary

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