BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MOZI TPS

    DI: 06973127400067 · Model: 1.3 · Manteia Technologies Co.,Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MOZI TPS
    Primary DI
    06973127400067
    Version / Model
    1.3
    Company Name
    Manteia Technologies Co.,Ltd.
    Labeler DUNS
    416535464
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-11-06
    Public Version
    1
    Public Version Date
    2023-11-14
    Public Version Status
    New
    Public Device Record Key
    61e137af-0009-4f41-8bea-dbd6be742056

    Device Description

    The MOZI Treatment Planning System (MOZI TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. MOZI TPS is used to plan external beam irradiation with photon beams.

    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
    MUJ System, Planning, Radiation Therapy Treatment

    GMDN Terms

    Code Name
    40887 Radiation therapy software

    Identifiers

    Type ID
    Primary 06973127400067

    Premarket Submissions

    Submission Number Supplement Number
    K223724 000