BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    BRIGHTONIX IMAGING INC.

    Reg #: 3034246184 · FEI: 3034246184 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BRIGHTONIX IMAGING INC.
    Registration Number
    3034246184
    FEI Number
    3034246184
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    #B203, #409, Seongsu AK Valley, 76, Yeonmujang-gil, Seongdong-gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K250170

    Owner / Operator

    Firm Name
    Brightonix Imaging Inc.
    Operator Number
    10091856
    Address
    #B203, #409, Seongsu AK Valley, 76, Yeonmujang-gil, Seongdong-gu
    City
    Seoul
    State
    KR-11
    Postal Code
    04784
    Country
    KR
    Correspondent
    Radcheck Yang

    US Agent

    Business Name
    Mtech Group LLC
    Contact Name
    Dave Kim
    Address
    7505 Fannin St Ste 610
    City
    Houston
    State
    TX
    ZIP
    77054
    Country
    US
    Email
    [email protected]
    Phone
    713 4672607

    Products

    Device Name Product Code
    System, Tomography, Computed, Emission KPS

    Proprietary Names

    PHAROS

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device