BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    SPECTRONIC MEDICAL AB

    Reg #: 3025309924 · FEI: 3025309924 · Expires 2026
    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
    2026
    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
    GE HealthCare Technologies, Inc
    Contact Name
    Tracey Holevas
    Address
    3000 N Grandview Blvd
    City
    Waukesha
    State
    WI
    ZIP
    53188
    Country
    US
    Email
    [email protected]
    Phone
    262 3092157

    Products

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

    Proprietary Names

    MRI Planner

    Establishment Types

    Manufacture Medical Device