BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    BriefCase for ICH, PE and CSF triage

    DI: 07290018052044 · Model: 3.0.0 · AIDOC MEDICAL LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BriefCase for ICH, PE and CSF triage
    Primary DI
    07290018052044
    Version / Model
    3.0.0
    Company Name
    AIDOC MEDICAL LTD
    Labeler DUNS
    532230094
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-11-17
    Public Version
    3
    Public Version Date
    2023-12-04
    Public Version Status
    Update
    Public Device Record Key
    ff074f1a-4755-4756-806e-07b43ef4269d
    Distribution End Date
    2021-01-01

    Device Description

    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.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QAS Radiological Computer-Assisted Triage And Notification Software

    GMDN Terms

    Code Name
    57812 Radiology DICOM image processing application software

    Identifiers

    Type ID
    Primary 07290018052044