BriefCase Triage

GUDID 07290018052211

BriefCase is a radiological computer aided triage and notification software

AIDOC MEDICAL LTD

Radiology DICOM image processing application software

• Primary Device ID: 07290018052211
• NIH Device Record Key: 11514d59-07dd-404c-952b-a90f69bf81d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BriefCase Triage
• Version Model Number: 19.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	07290018052211 [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: 2023-07-24
• Device Publish Date: 2023-07-14

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
• 07290018052297: BriefCase is a radiological computer aided triage and notification software
• 07290018052273: BriefCase is a radiological computer aided triage and notification software