aiOS

GUDID 07290018052198

The AI Operating System (aiOS) is a Medical Image Communication Device, indicated to route radiological studies for processing by Integrated AI Solutions (IAIS), and to display their results.

AIDOC MEDICAL LTD

Radiology DICOM image processing application software

• Primary Device ID: 07290018052198
• NIH Device Record Key: 349be348-5218-4d2a-8790-96910cda638c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: aiOS
• Version Model Number: 3.x.y
• Company DUNS: 532230094
• Company Name: AIDOC MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	07290018052198 [Primary]

FDA Product Code

• LMD: System, Digital Image Communications, Radiological

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

Devices Manufactured by AIDOC MEDICAL LTD

• 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: 2023-07-24The AI Operating System (aiOS) is a Medical Image Communication Device, indicated to route radiological studies for processing by Integrated AI Solutions (IAIS), and to display their results.
• 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
• 07290018052044 - BriefCase for ICH, PE and CSF triage: 2019-11-25 BriefCase is a radiological computer aided triage and notification software device. The device contains the software platform a
• 07290018052013 - BriefCase: 2019-10-07 BriefCase is a radiological computer aided triage and notification software device. Software version 1.1.0.0 for ICH triage.
• 07290018052020 - BriefCase: 2019-10-07 BriefCase is a radiological computer aided triage and notification software device. Software version 2.0.0 for PE triage