BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BodyTom 64

    Reg #: 3004938766 · FEI: 3004938766 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NeuroLogica Corp., a Samsung Company
    Registration Number
    3004938766
    FEI Number
    3004938766
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    14 ELECTRONICS AVENUE
    City
    Danvers
    State
    MA
    ZIP
    01923
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213649

    Owner / Operator

    Firm Name
    Samsung Electronics Co., Ltd.
    Operator Number
    10043488
    Address
    129, Samsung-ro, Yeongtong-gu
    City
    Suwon-si
    State
    Gyeonggi
    Postal Code
    16677
    Country
    KR

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    BodyTom 64

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device