Eclipse Treatment Planning System for External Beam Radiation Therapy

GUDID 00855141006059

Varian Medical Systems Finland Oy

Radiation therapy software

• Primary Device ID: 00855141006059
• NIH Device Record Key: 2945df4d-75c2-4610-9a2b-9bcce48df3dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eclipse Treatment Planning System for External Beam Radiation Therapy
• Version Model Number: 15.5
• 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	00855141006059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172163

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-18
• Device Publish Date: 2019-11-08

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

• 00855141006066: 15.6
• 00855141006059: 15.5