Proton Systems, LLC

GUDID 00861206000368

Proton Systems Radiation Therapy Beam Shaping Range Compensator is custom manufactured and designed by the customer for intensity modulation of external beam proton radiation therapy. Each Compensator is patient specific and for single use

PROTON SYSTEMS VIRGINIA LLC

Radiation therapy beam block material

• Primary Device ID: 00861206000368
• NIH Device Record Key: 926bc313-0f6b-44a7-be36-f841de5dd360
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Proton Systems, LLC
• Version Model Number: 25cm Wax Range Compensator
• Company DUNS: 048148197
• Company Name: PROTON SYSTEMS VIRGINIA LLC
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861206000368 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121657

FDA Product Code

• IYE: Accelerator, Linear, 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: 2018-03-29
• Device Publish Date: 2016-12-02

On-Brand Devices [Proton Systems, LLC]

• 00861206000382: Proton Systems Radiation Therapy Beam Shaping Range Compensator is custom manufactured and desig
• 00861206000375: Proton Systems Radiation Therapy Beam-Shaping Aperture is designed by the customer to block and
• 00861206000368: Proton Systems Radiation Therapy Beam Shaping Range Compensator is custom manufactured and desig
• 00861206000351: Proton Systems Radiation Therapy Beam-Shaping Aperture is designed by the customer to block and
• 00861206000344: Proton Systems Radiation Therapy Beam Shaping Range Compensator is custom manufactured and desig
• 00861206000337: Proton Systems Radiation Therapy Beam-Shaping Aperture is designed by the customer to block and