Triage ICH

GUDID B720BX360TRIAGEICH1400

BRAINOMIX LIMITED

X-ray image interpretive software

• Primary Device ID: B720BX360TRIAGEICH1400
• NIH Device Record Key: 302c586d-485b-4d0e-bb1d-d6e2bf4ab7a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Triage ICH
• Version Model Number: 14.0
• 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	B720BX360TRIAGEICH1400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231195

FDA Product Code

• QAS: Radiological Computer-Assisted Triage And Notification Software

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: 2025-08-26
• Device Publish Date: 2025-08-18

On-Brand Devices [Triage ICH]

• B720BX360TRIAGEICH1110: 11.1
• B720BX360TRIAGEICH1400: 14.0