BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    SMART Bun-Yo-Matic™ Xray

    Reg #: 3018064242 · FEI: 3018064242 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DISIOR OY
    Registration Number
    3018064242
    FEI Number
    3018064242
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    HTC Helsinki, Building Pinta, Tammasaarenkatu 3
    City
    Helsinki Uusimaa
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K240736

    Owner / Operator

    Firm Name
    Disior Oy
    Operator Number
    10077636
    Address
    HTC Helsinki, Building Pinta, Tammasaarenkatu 3
    City
    Helsinki
    State
    Uusimaa
    Postal Code
    00180
    Country
    FI
    Correspondent
    Anna-Maria Henell

    US Agent

    Business Name
    PARAGON28
    Contact Name
    Steven Mounts
    Address
    14445 Grasslands Dr
    City
    Englewood
    State
    CO
    ZIP
    80112
    Country
    US
    Email
    [email protected]
    Phone
    855 7862828

    Products

    Device Name Product Code
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    SMART Bun-Yo-Matic™ Xray

    Establishment Types

    Manufacture Medical Device