Eclipse Treatment Planning System for External Beam Radiation Therapy

GUDID 00855141006035

VARIAN MEDICAL SYSTEMS, INC.

Radiation therapy software
Primary Device ID00855141006035
NIH Device Record Key70a48b62-6a61-4986-a61b-eca8db08f5e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameEclipse Treatment Planning System for External Beam Radiation Therapy
Version Model Number13.6
Company DUNS009120817
Company NameVARIAN MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100855141006035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUJSystem, planning, radiation therapy treatment

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-14
Device Publish Date2020-07-06

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