VBrain

GUDID 04719884900011

Vysioneer Inc.

Radiology DICOM image processing application software

• Primary Device ID: 04719884900011
• NIH Device Record Key: ae7d8602-152d-4258-a55e-2d0de10039d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VBrain
• Version Model Number: 2.1.2
• Company DUNS: 117656080
• Company Name: Vysioneer 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	04719884900011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213628

FDA Product Code

• QKB: Radiological Image Processing Software For Radiation Therapy

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: 2023-08-16
• Device Publish Date: 2023-08-08