BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IMAGEnet 6

    DI: 00850003069005 · Model: 2.0 · TOPCON HEALTHCARE SOLUTIONS, INC.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    IMAGEnet 6
    Primary DI
    00850003069005
    Version / Model
    2.0
    Company Name
    TOPCON HEALTHCARE SOLUTIONS, INC.
    Labeler DUNS
    081155097
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-02-12
    Public Version
    2
    Public Version Date
    2019-09-16
    Public Version Status
    Update
    Public Device Record Key
    b0b8f3d8-bae5-4b0f-a9d1-3003d59a230f

    Device Description

    The IMAGEnet 6 ver. 2.0 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices.

    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
    NFJ System, Image Management, Ophthalmic
    HKI Camera, Ophthalmic, Ac-Powered
    OBO Tomography, Optical Coherence

    GMDN Terms

    Code Name
    38683 Camera application software

    Identifiers

    Type ID
    Primary 00850003069005