BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PLANET, PLANET Onco, PLANET Dose, PLANET Onco Dose

    DI: B501PLANET030101 · Model: 3.1.1 · DOSISOFT
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PLANET, PLANET Onco, PLANET Dose, PLANET Onco Dose
    Primary DI
    B501PLANET030101
    Version / Model
    3.1.1
    Catalog Number
    3.1.1
    Company Name
    DOSISOFT
    Labeler DUNS
    264815932
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-01-30
    Public Version
    1
    Public Version Date
    2020-02-07
    Public Version Status
    New
    Public Device Record Key
    01d4e834-568d-4d18-a660-a3d8d2646868

    Device Description

    PLANET Onco Dose is a software platform dedicated to medical diagnosis aid, therapy response assessment aid, contouring for radiotherapy and internal dosimetry computation, using molecular imaging modalities.

    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
    40887 Radiation therapy software

    Identifiers

    Type ID
    Primary B501PLANET030101

    Premarket Submissions

    Submission Number Supplement Number
    K182966 000