ARIA Radiation Therapy Management (RTM)

GUDID 00856100006165

VARIAN MEDICAL SYSTEMS, INC.

Radiation therapy treatment record/verify system

• Primary Device ID: 00856100006165
• NIH Device Record Key: 9c82588f-f8f1-47e2-b831-2e43256ddba0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARIA Radiation Therapy Management (RTM)
• Version Model Number: 16.1
• Company DUNS: 009120817
• Company Name: VARIAN 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: true
• Serial Number: false
• 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	00856100006165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173838

FDA Product Code

• IYE: Accelerator, linear, 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: 2020-10-06
• Device Publish Date: 2020-09-28

On-Brand Devices [ARIA Radiation Therapy Management (RTM)]

• 00856100006165: 16.1
• 00856100006189: 17.0