e-ASPECTS

GUDID B720BX360EASPECTS1110

BRAINOMIX LIMITED

X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software

• Primary Device ID: B720BX360EASPECTS1110
• NIH Device Record Key: 97b15676-c55a-4cd8-a493-8f173bcc103f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: e-ASPECTS
• 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	B720BX360EASPECTS1110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221564

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: 2023-04-14
• Device Publish Date: 2023-04-06

Devices Manufactured by BRAINOMIX LIMITED

• B720BX360TRIAGESTRO1120 - Triage Stroke: 2023-12-15
• B720BX360TRIAGELVO1110 - Triage LVO: 2023-10-11
• B720BX360EMRI1110 - e-MRI: 2023-09-13
• B720BX360TRIAGEICH1110 - Triage ICH: 2023-09-13
• B720BX360ECTP1110 - e-CTP: 2023-07-14
• B720BX360EASPECTS1110 - e-ASPECTS: 2023-04-14
• B720BX360EASPECTS1110 - e-ASPECTS: 2023-04-14
• B720BX360ECTA1110 - e-CTA: 2023-04-14