BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Harmony

    DI: 00850003069296 · Model: 5.06.003 · TOPCON HEALTHCARE SOLUTIONS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Harmony
    Primary DI
    00850003069296
    Version / Model
    5.06.003
    Company Name
    TOPCON HEALTHCARE SOLUTIONS, INC.
    Labeler DUNS
    081155097
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-02-09
    Public Version
    1
    Public Version Date
    2021-02-17
    Public Version Status
    New
    Public Device Record Key
    09419997-13ba-45a4-b126-d55ef7141399

    Device Description

    Harmony 5.06.003 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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

    GMDN Terms

    Code Name
    38683 Camera application software

    Identifiers

    Type ID
    Primary 00850003069296

    Premarket Submissions

    Submission Number Supplement Number
    K182376 000