BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    MRI Planner

    Reg #: 3025309924 · FEI: 3025309924 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SPECTRONIC MEDICAL AB
    Registration Number
    3025309924
    FEI Number
    3025309924
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Karbingatan 36
    City
    Helsingborg Skane
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K211841

    Owner / Operator

    Firm Name
    Spectronic Medical AB
    Operator Number
    10086591
    Address
    Karbingatan 36
    City
    Helsingborg
    State
    Skane
    Postal Code
    25467
    Country
    SE
    Correspondent
    Per Bruhn

    US Agent

    Business Name
    FDAbasics LLC
    Contact Name
    Jerry Doane
    Address
    15815 Sw 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    System, Planning, Radiation Therapy Treatment MUJ
    Radiological Image Processing Software For Radiation Therapy QKB

    Proprietary Names

    MRI Planner

    Establishment Types

    Manufacture Medical Device