BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office

    Reg #: 3032109225 · FEI: 3032109225 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    109
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office
    Registration Number
    3032109225
    FEI Number
    3032109225
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2-1, Shintoyofuta
    City
    Kashiwa-shi Chiba
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K123828

    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, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    System, X-Ray, Tomography, Computed JAK
    System, Nuclear Magnetic Resonance Imaging LNH
    Coil, Magnetic Resonance, Specialty MOS
    System, Nuclear Magnetic Resonance Spectroscopic LNI

    Proprietary Names

    Prosound 75 Supria Whole-Body X-Ray CT System APERTO LUCENT MRI System L44LA ARIETTA Prologue SCENARIA View Prosound F37 ECHELON OVAL MRI SYSTEM ARIETTA 60 / ARIETTA S60 / ARIETTA V60 CL4416R C41L47RP C23 CC41R2 UST-2265-2 L43K C25P VC35 C253 L46K1 S11 C42T R41R C251 L53K L44K UST-2266-5 L52H CL4416R1 VC34 L44LA1 S3ESCLS L31KP L35 VC41V C22K C22P C41B S31 S121 C252 CC41R S3ESEL L55 L442 C41RP C23RV L441 S42 Aloka Arietta 850 C42 L51K L34 S3ESL1 ARIETTA 850 CC41R1 C42K C41V1 MXS1 R41RL C35 SML44 L64 ECHELON Synergy MRI System FCT iStream Phase 1 OASIS Magnetic Resonance Imaging System Prosound 6 Prosound Alpha 7 C41V C23RV/C23 C421 C253A ARIETTA 50 OASIS Rapid Breast Coil, Oasis Rapid NV Coil APERTO Lucent MRI System UST-5310 and UST-5311 Prosound Alpha 7, ARIETTA 70 ECHELON Synergy UST-5311 UST-5310 ARIETTA Precision C22T C22i S31KP MXS2ESLL1 MXS2ESLL Lisendo 880 ARIETTA 65 ARIETTA 650 OASIS MRI System ARIETTA x10 C22I EUP-L53L C41 L43LAP L43KM ARIETTA 750 OASIS CTL Coil, OASIS OD Flexible Body Coil (L AND XL), OASIS Rapid Foot Coil HI VISION ASCENDUS OASIS Velocity MRI System Prosound 2 Prosound Alpha 6 UST-5310 and UST-5311 Prosound Alpha 6 ECHELON Synergy V10 MRI system Noblus ALOKA SSD-Alpha 7 Echelon Rapid Cardiac/Hip Coil SCENARIA View Phase 5 ARIETTA 70 Arietta 65 S211

    Establishment Types

    Manufacture Medical Device