PRONOVA SC360

GUDID 00863274000301

Proton Therapy System

PRONOVA SOLUTIONS, LLC

Proton therapy system

• Primary Device ID: 00863274000301
• NIH Device Record Key: aaaedcc4-1118-4636-b684-f1f0cc0ab5e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRONOVA SC360
• Version Model Number: R1.0
• Company DUNS: 968714563
• Company Name: PRONOVA SOLUTIONS, 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863274000301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162246

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: 2018-10-10
• Device Publish Date: 2018-02-19

On-Brand Devices [PRONOVA SC360]

• 00863274000318: Proton Therapy System
• 00863274000301: Proton Therapy System