Vitesee

GUDID 00850800006074

VARIAN MEDICAL SYSTEMS, INC.

Radiation therapy software

• Primary Device ID: 00850800006074
• NIH Device Record Key: b7893e47-3e52-4b19-a514-6be2e70f638b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitesee
• Version Model Number: 5.0
• Company DUNS: 009120817
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• 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: true
• 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	00850800006074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241876

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: 2024-11-11
• Device Publish Date: 2024-11-01

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

• 00810563022957 - Titanium Flexible Geometry FSD Applicator Set: 2025-05-30
• 00810563022995 - Ovoid pair, mini ø 16 mm: 2025-05-30
• 00810563023008 - Ovoid mini Ø16 mm Left: 2025-05-30
• 00810563023015 - Ovoid mini Ø16 mm Right: 2025-05-30
• 00855141006417 - MaximQA: 2025-03-12
• 00858086006818 - IDENTIFY: 2025-03-05
• 30816389027290 - Fixation buttons, pack of 10, sterile: 2025-02-21
• 00855141006349 - Eclipse Treatment Planning System: 2024-12-30