BriefCase

GUDID 07290018052013

BriefCase is a radiological computer aided triage and notification software device. Software version 1.1.0.0 for ICH triage.

AIDOC MEDICAL LTD

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• Primary Device ID: 07290018052013
• NIH Device Record Key: bf54afc4-ff6e-4b01-9467-24d551f79ba8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BriefCase
• Version Model Number: 1.1.0.0
• 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: true
• 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	07290018052013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180647

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-07
• Device Publish Date: 2019-09-01

On-Brand Devices [BriefCase]

• 07290018052037: BriefCase is a radiological computer aided triage and notification software device. Software ver
• 07290018052020: BriefCase is a radiological computer aided triage and notification software device. Software ver
• 07290018052013: BriefCase is a radiological computer aided triage and notification software device. Software ver