BriefCase for ICH, PE and CSF triage

GUDID 07290018052044

BriefCase is a radiological computer aided triage and notification software device. The device contains the software platform and image analysis algorithms for ICH, PE and CSF triage.

AIDOC MEDICAL LTD

Radiology DICOM image processing application software

• Primary Device ID: 07290018052044
• NIH Device Record Key: ff074f1a-4755-4756-806e-07b43ef4269d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BriefCase for ICH, PE and CSF triage
• Version Model Number: 3.0.0
• 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: 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
GS1	07290018052044 [Primary]

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: 2019-11-25
• Device Publish Date: 2019-11-17

Devices Manufactured by AIDOC MEDICAL LTD

• 07290018052280 - BriefCase-Quantification: 2025-03-13 BriefCase-Quantification is an Automated Radiological Image Processing Software.
• 07290018052273 - BriefCase Triage: 2024-12-02 BriefCase is a radiological computer aided triage and notification software
• 07290018052297 - BriefCase Triage: 2024-12-02 BriefCase is a radiological computer aided triage and notification software
• 07290018052235 - BriefCase-Quantification: 2024-07-12 BriefCase-Quantification is an Automated Radiological Image Processing Software.
• 07290018052266 - BriefCase-Quantification: 2024-06-12 BriefCase-Quantification is an Automated Radiological Image Processing Software.
• 07290018052259 - BriefCase Triage: 2024-01-04 BriefCase is a radiological computer aided triage and notification software
• 07290018052198 - aiOS: 2023-07-24 The AI Operating System (aiOS) is a Medical Image Communication Device, indicated to route radiological studies for processing b
• 07290018052211 - BriefCase Triage: 2023-07-24 BriefCase is a radiological computer aided triage and notification software