BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ImageQube

    DI: B688IMAGEQUBE0 · Model: ImageQube · INTUITIVE IMAGING INFORMATICS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ImageQube
    Primary DI
    B688IMAGEQUBE0
    Version / Model
    ImageQube
    Company Name
    INTUITIVE IMAGING INFORMATICS, LLC
    Labeler DUNS
    086797144
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-20
    Public Version
    1
    Public Version Date
    2018-10-22
    Public Version Status
    New
    Public Device Record Key
    5d6e6f33-3a7e-422d-b191-d6cfef01d6a3

    Device Description

    ImageQube, Intuitive Imaging Informatics Picture Archiving and Communication System (PACS), is a medical imaging information system that securely transmits, receives, and archives digitally transmitted images and provides radiologists access to patient information, medical images, annotated print pages, transcribed reports.

    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
    LLZ System, Image Processing, Radiological

    GMDN Terms

    Code Name
    40943 Radiology picture archiving and communication system workstation

    Identifiers

    Type ID
    Primary B688IMAGEQUBE0