Radiance 330

GUDID 00861552000418

Radiance 330 Proton Therapy System

PROTOM INTERNATIONAL HOLDING CORPORATION

Proton therapy system

• Primary Device ID: 00861552000418
• NIH Device Record Key: d0f7348c-b226-4171-ad58-3429f046d664
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radiance 330
• Version Model Number: 1001
• Company DUNS: 080545604
• Company Name: PROTOM INTERNATIONAL HOLDING CORPORATION
• 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: 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	00861552000418 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191521

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: 2020-04-01
• Device Publish Date: 2020-03-24