BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Lunit INSIGHT DBT

    Reg #: 3021230777 · FEI: 3021230777 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    LUNIT INC.
    Registration Number
    3021230777
    FEI Number
    3021230777
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4-8F, 374, Gangnam-daero, Gangnam-gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K231470

    Owner / Operator

    Firm Name
    Lunit Inc.
    Operator Number
    10076093
    Address
    4-8 F, 374, Gangnam-daero, Gangnam-gu
    City
    Seoul
    State
    KR-11
    Postal Code
    06241
    Country
    KR
    Correspondent
    Suhyoung Bahk

    US Agent

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

    Products

    Device Name Product Code
    Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer QDQ

    Proprietary Names

    Lunit INSIGHT DBT

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198