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 IDK181145
510k NumberK181145
Device Name:Eclipse Treatment Planning System
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant Varian Medical Systems, Inc. 911 Hensen Way Palo Alto,  CA  94304
ContactPeter J. Coronado
CorrespondentPeter J. Coronado
Varian Medical Systems, Inc. 911 Hensen Way Palo Alto,  CA  94304
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-01
Decision Date2018-05-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00855141006066 K181145 000
00855141006035 K181145 000

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