RT Elements - RT QA

GUDID 04056481142124

Brainlab AG

Radiation therapy software

• Primary Device ID: 04056481142124
• NIH Device Record Key: 5ce29e60-1f5c-4cb2-850e-6d59f83b50b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RT Elements - RT QA
• Version Model Number: 3.0
• Company DUNS: 314482980
• Company Name: Brainlab AG
• 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: false
• 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	04056481142124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170750

FDA Product Code

• MUJ: System, Planning, Radiation Therapy Treatment

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: 2020-11-30
• Device Publish Date: 2020-11-20

On-Brand Devices [RT Elements - RT QA]

• 04056481140694: 2.0
• 04056481142124: 3.0