BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa

    Reg #: 3018423337 · FEI: 3018423337 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa
    Registration Number
    3018423337
    FEI Number
    3018423337
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2-1, SHINTOYOFUTA
    City
    KASHIWA-SHI Chiba
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K202030

    Owner / Operator

    Firm Name
    FUJIFILM Corporation
    Operator Number
    10081521
    Address
    26-30, Nishiazabu 2-chome
    City
    Minato-ku
    State
    Tokyo
    Postal Code
    106-8620
    Country
    JP

    US Agent

    Business Name
    FUJIFILM Healthcare Americas Corporation
    Contact Name
    Randy Vader
    Address
    81 Hartwell Ave Ste 100
    City
    Lexington
    State
    MA
    ZIP
    02421
    Country
    US
    Email
    [email protected]
    Phone
    360 3566821

    Products

    Device Name Product Code
    System, Nuclear Magnetic Resonance Imaging LNH
    System, X-Ray, Tomography, Computed JAK
    Coil, Magnetic Resonance, Specialty MOS
    System, Nuclear Magnetic Resonance Spectroscopic LNI

    Proprietary Names

    OASIS MRI System OASIS Velocity MRI System SCENARIA View ECHELON OVAL MRI SYSTEM APERTO Lucent MRI System OASIS CTL Coil, OASIS OD Flexible Body Coil (L AND XL), OASIS Rapid Foot Coil ECHELON Synergy MRI System Supria Whole-Body X-Ray CT System SCENARIA View Phase 5 OASIS Rapid Breast Coil, Oasis Rapid NV Coil ECHELON Synergy FCT iStream Phase 1 OASIS Magnetic Resonance Imaging System Echelon Rapid Cardiac/Hip Coil APERTO LUCENT MRI System ECHELON Synergy V10 MRI system

    Establishment Types

    Manufacture Medical Device