e-MRI

GUDID B720BX360EMRI1110

BRAINOMIX LIMITED

X-ray image interpretive software

• Primary Device ID: B720BX360EMRI1110
• NIH Device Record Key: 39a18232-95eb-4e5e-b39b-91eafc30fb19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: e-MRI
• Version Model Number: 11.1
• Company DUNS: 216967482
• Company Name: BRAINOMIX LIMITED
• 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: 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
HIBCC	B720BX360EMRI1110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231656

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2023-09-13
• Device Publish Date: 2023-09-05

On-Brand Devices [e-MRI]

• B720BX360EMRI1110: 11.1
• B720BX360EMRI1420: 14.2