BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TOMTEC-ARENA

    DI: 04260361440211 · Model: TTA2.52 · TOMTEC Imaging Systems GmbH
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TOMTEC-ARENA
    Primary DI
    04260361440211
    Version / Model
    TTA2.52
    Company Name
    TOMTEC Imaging Systems GmbH
    Labeler DUNS
    537711462
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-09-06
    Public Version
    2
    Public Version Date
    2023-10-18
    Public Version Status
    Update
    Public Device Record Key
    a1c8de40-5667-49a0-9830-e926ceb779a2

    Device Description

    TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to be used for reading of mammography images.

    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QIH Automated Radiological Image Processing Software
    LLZ System, Image Processing, Radiological

    GMDN Terms

    Code Name
    41670 Radiological PACS software

    Identifiers

    Type ID
    Primary 04260361440211