BriefCase Triage

GUDID 07290018052259

BriefCase is a radiological computer aided triage and notification software

AIDOC MEDICAL LTD

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• Primary Device ID: 07290018052259
• NIH Device Record Key: e3b63359-68d8-4037-9b2c-73d4a90113b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BriefCase Triage
• Version Model Number: 21.x.y
• Company DUNS: 532230094
• Company Name: AIDOC MEDICAL LTD
• 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: 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
GS1	07290018052259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190896

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: 2024-01-04
• Device Publish Date: 2023-12-27

On-Brand Devices [BriefCase Triage]

• 07290018052211: BriefCase is a radiological computer aided triage and notification software
• 07290018052259: BriefCase is a radiological computer aided triage and notification software