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 IDK073020
510k NumberK073020
Device Name:ECLIPSE TREATMENT PLANNING SYSTEM
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY, E-110 Palo Alto,  CA  94304 -1129
ContactVy Tran
CorrespondentVy Tran
VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY, E-110 Palo Alto,  CA  94304 -1129
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-26
Decision Date2007-12-19
Summary:summary

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