BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    ONTACT HEALTH CO., LTD.

    Reg #: 3044776706 · FEI: 3044776706 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ONTACT HEALTH CO., LTD.
    Registration Number
    3044776706
    FEI Number
    3044776706
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    184, Jungang-daero, Dong-gu
    City
    Busan
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K240645

    Owner / Operator

    Firm Name
    ONTACT HEALTH Co., Ltd.
    Operator Number
    10095526
    Address
    184, Jungang-daero, Dong-gu
    City
    Busan
    State
    KR-26
    Postal Code
    48821
    Country
    KR
    Correspondent
    Hyuk jae Chang

    US Agent

    Business Name
    Young Ji Lee
    Contact Name
    Youngji Lee
    Address
    89 Needham St Apt 2239
    City
    Newton
    State
    MA
    ZIP
    02461
    Country
    US
    Email
    [email protected]
    Phone
    201 8151498

    Products

    Device Name Product Code
    Automated Radiological Image Processing Software QIH
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Sonix Health

    Establishment Types

    Manufacture Medical Device