Eclipse Treatment Planning System

GUDID 00855141006011

Varian Medical Systems Finland Oy

Radiation therapy software

• Primary Device ID: 00855141006011
• NIH Device Record Key: e8e6a83f-6615-4713-994f-04cfecb9b168
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eclipse Treatment Planning System
• Version Model Number: 15.0
• Company DUNS: 540164027
• Company Name: Varian Medical Systems Finland Oy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855141006011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152393

FDA Product Code

• MUJ: System,planning,radiation therapy treatment

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-16

On-Brand Devices [Eclipse Treatment Planning System]

• 00855141006011: 15.0
• 00855141006004: 13.7