Eclipse Treatment Planning System for External Beam Radiation Therapy

GUDID 00855141006059

Varian Medical Systems Finland Oy

Radiation therapy software
Primary Device ID00855141006059
NIH Device Record Key2945df4d-75c2-4610-9a2b-9bcce48df3dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameEclipse Treatment Planning System for External Beam Radiation Therapy
Version Model Number15.5
Company DUNS540164027
Company NameVarian Medical Systems Finland Oy
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
GS100855141006059 [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 Date2019-11-18
Device Publish Date2019-11-08

On-Brand Devices [Eclipse Treatment Planning System for External Beam Radiation Therapy]

0085514100606615.6
0085514100605915.5

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