BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    AcuityDR 1717 G4

    Reg #: 3015464948 · FEI: 3015464948 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    IRAY KOREA LIMITED
    Registration Number
    3015464948
    FEI Number
    3015464948
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1833, 18F, 5, Gasan digital 1-ro, Geumcheon-gu, Seoul, Republic of Korea 08594
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K231709

    Owner / Operator

    Firm Name
    iRay Korea Limited
    Operator Number
    10060342
    Address
    1833, 18F, 5, Gasan digital 1-ro, Geumcheon-gu, Seoul, Republic of Korea 08594
    City
    Seoul
    State
    KR-11
    Postal Code
    08594
    Country
    KR
    Correspondent
    Johnny Jung

    US Agent

    Business Name
    MID-LINK INTERNATIONAL CO., Ltd
    Contact Name
    Marco Mu
    Address
    2219 Rimlang Drive, Suite 301, Bellingham-Barkley Villiage, WA, 98226
    City
    Bakerview
    State
    WA
    ZIP
    98226
    Country
    US
    Email
    [email protected]
    Phone
    360 3257028

    Products

    Device Name Product Code
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, Image Processing, Radiological LLZ

    Proprietary Names

    AcuityDR 1717 G4 AcuityDR 1417 G4 AcuityDR 1013 G4

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)