e-ASPECTS

GUDID B720BX360EASPECTS113

BRAINOMIX LIMITED

X-ray image interpretive software

• Primary Device ID: B720BX360EASPECTS113
• NIH Device Record Key: d4b0da0a-4f94-48f7-9184-021a13a8ac24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: e-ASPECTS
• Version Model Number: 11.3
• 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	B720BX360EASPECTS113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243294

FDA Product Code

• POK: Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

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: 2025-04-23
• Device Publish Date: 2025-04-15

On-Brand Devices [e-ASPECTS]

• B720BX360EASPECTS1110: 11.1
• B720BX360EASPECTS113: 11.3