BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    JLK, INC.

    Reg #: 3038177848 · FEI: 3038177848 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    JLK, INC.
    Registration Number
    3038177848
    FEI Number
    3038177848
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Teheranro33-Gil 5/11f
    City
    Gangnam Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K243363

    Owner / Operator

    Firm Name
    JLK Inc
    Operator Number
    10092928
    Address
    11F, 5, Teheran-ro 33-gil
    City
    Gangnam-gu
    State
    Seoul
    Postal Code
    06141
    Country
    KR

    US Agent

    Business Name
    JLK USA, Inc.
    Contact Name
    Heesun Kim
    Address
    5201 Great America Pkwy Ste 407
    City
    Santa Clara
    State
    CA
    ZIP
    95054
    Country
    US
    Email
    [email protected]
    Phone
    530 5749393

    Products

    Device Name Product Code
    Radiological Computer-Assisted Triage And Notification Software QAS
    System, Image Processing, Radiological LLZ
    System, Digital Image Communications, Radiological LMD
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    JLK-ICH JLK-LVO JLK-PWI JLK-SDH JLK-CTP FASTRO Medihub Prostate JLK-AILink JLK-NCCT

    Establishment Types

    Manufacture Medical Device