ProBeam Proton Therapy System - Rotating Gantry

GUDID 00858991006132

Varian Medical Systems Particle Therapy GmbH & Co. KG

Proton therapy system

• Primary Device ID: 00858991006132
• NIH Device Record Key: 281eccf5-3cdb-4430-a992-6198119de1f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProBeam Proton Therapy System - Rotating Gantry
• Version Model Number: 4.3 MR6
• Company DUNS: 342623907
• Company Name: Varian Medical Systems Particle Therapy GmbH & Co. KG
• 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: true
• 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	00858991006132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133191

FDA Product Code

• LHN: System, Radiation Therapy, Charged-Particle, Medical

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: 2025-05-07
• Device Publish Date: 2025-04-29

Devices Manufactured by Varian Medical Systems Particle Therapy GmbH & Co. KG

• 00858991006132 - ProBeam Proton Therapy System - Rotating Gantry: 2025-05-07
• 00858991006132 - ProBeam Proton Therapy System - Rotating Gantry: 2025-05-07
• 00858991006149 - ProBeam Proton Therapy System - Fixed Beam Room: 2025-05-07