ProBeam® Fixed Beam Proton Therapy System

GUDID 00858991006026

Fixed Beam

Varian Medical Systems Particle Therapy GmbH

Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system

• Primary Device ID: 00858991006026
• NIH Device Record Key: 68299ce8-4201-4f13-bb1d-6373edfaab0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProBeam® Fixed Beam Proton Therapy System
• Version Model Number: 3.5
• Company DUNS: 342623907
• Company Name: Varian Medical Systems Particle Therapy GmbH
• 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: false
• 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	00858991006026 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-04
• Device Publish Date: 2019-09-12

Devices Manufactured by Varian Medical Systems Particle Therapy GmbH

• 00858991006088 - ProBeam 360 Proton Therapy System - Rotating Gantry: 2023-11-02
• 00858991006071 - ProBeam 360 Proton Therapy System - Rotaiting Gantry: 2022-12-14
• 00858991006026 - ProBeam® Fixed Beam Proton Therapy System: 2019-10-04Fixed Beam
• 00858991006026 - ProBeam® Fixed Beam Proton Therapy System: 2019-10-04 Fixed Beam
• 00858991006033 - ProBeam® Rotating Gantry Proton Therapy System: 2019-10-04 Rotating Gantry
• 00858991006040 - ProBeam® Rotating Gantry Proton Therapy System: 2019-10-04
• 00858991006002 - ProBeam Proton Therapy System: 2018-07-06 Rotating Gantry
• 00858991006019 - ProBeam Proton Therapy System: 2018-07-06 Fixed Beam