Mevion Medical Systems MEVION S250

GUDID 00864366000100

Proton Beam Radiation Therapy System

MEVION MEDICAL SYSTEMS, INC.

Proton therapy system

• Primary Device ID: 00864366000100
• NIH Device Record Key: 33c318f9-93da-4d9a-a03b-b30962ba4c47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mevion Medical Systems
• Version Model Number: S250
• Catalog Number: MEVION S250
• Company DUNS: 199652145
• Company Name: MEVION 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: 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864366000100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120676

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-06

Devices Manufactured by MEVION MEDICAL SYSTEMS, INC.

• 00864366000100 - Mevion Medical Systems: 2018-07-06Proton Beam Radiation Therapy System
• 00864366000100 - Mevion Medical Systems: 2018-07-06 Proton Beam Radiation Therapy System
• 00864366000124 - MEVION S250i: 2018-07-06