BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    FUJIFILM Corporation Medical Systems Research & Development Center Kokubunji

    Reg #: 3019784575 · FEI: 3019784575 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    93
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    FUJIFILM Corporation Medical Systems Research & Development Center Kokubunji
    Registration Number
    3019784575
    FEI Number
    3019784575
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3-1-1 HIGASHIKOIGAKUBO
    City
    KOKUBUNJI-SHI Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K140854

    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
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    UST-5310 and UST-5311 Prosound Alpha 6 C253 L34 C41RP ARIETTA 50 C42K S11 CC41R L442 C421 L44K VC35 VC41V C253A L64 L53K C41L47RP L51K C35 C22P S31 C23RV/C23 C41B C251 CL4416R1 C22K C25P UST-2265-2 CC41R2 C41V L55 L43K C41V1 ARIETTA x10 C23RV L31KP L44LA R41R UST-2266-5 C252 S121 S3ESEL C42T L441 L46K1 L44LA1 C22I EUP-L53L C41 L43LAP C23 L35 SML44 C22T L43KM C42 S3ESL1 L52H MXS1 R41RL ARIETTA 750 CL4416R S3ESCLS S42 S31KP HI VISION ASCENDUS Prosound 6 VC34 Aloka Arietta 850 ARIETTA 850 CC41R1 ARIETTA 70 Prosound Alpha 6 Arietta 65 S211 ARIETTA Prologue ARIETTA 60 / ARIETTA S60 / ARIETTA V60 Prosound 2 UST-5310 and UST-5311 Prosound Alpha 7, ARIETTA 70 UST-5311 UST-5310 ARIETTA Precision C22i MXS2ESLL1 MXS2ESLL Lisendo 880 Prosound Alpha 7 Prosound F37 ARIETTA 65 ARIETTA 650 ALOKA SSD-Alpha 7 Prosound 75 Noblus

    Establishment Types

    Manufacture Medical Device