ARIA Radiation Therapy Management Software

GUDID 00856100006097

Varian Medical Systems Imaging Laboratory GmbH

Radiation therapy treatment record/verify system

• Primary Device ID: 00856100006097
• NIH Device Record Key: 7df0aad7-4a72-4c5b-84df-d17cf90337dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARIA Radiation Therapy Management Software
• Version Model Number: 15.5
• Company DUNS: 482243784
• Company Name: Varian Medical Systems Imaging Laboratory GmbH
• 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: 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	00856100006097 [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: 2019-11-18
• Device Publish Date: 2019-11-08

On-Brand Devices [ARIA Radiation Therapy Management Software]

• 00856100006110: 15.6
• 00856100006097: 15.5
• 00856100006127: 16.0