BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    FUJIFILM Corporation Medical Systems Research & Development Center Minamiaoyama

    Reg #: 3005930550 · FEI: 3005930550 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    FUJIFILM Corporation Medical Systems Research & Development Center Minamiaoyama
    Registration Number
    3005930550
    FEI Number
    3005930550
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6 Chome 6-15, Minamiaoyama
    City
    Minato Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K221677

    Owner / Operator

    Firm Name
    FUJIFILM CORPORATION
    Operator Number
    8031568
    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, Image Processing, Radiological LLZ
    Automated Radiological Image Processing Software QIH
    System, X-Ray, Tomography, Computed JAK
    Lung Computed Tomography System, Computer-Aided Detection OEB

    Proprietary Names

    Synapse 3D Base Tools V6.6 Synapse 3D Base Tools V7 Synapse 3D Cardiac Tools Synapse 3D Optional Tools Endoscope Simulator Synapse 3D Lung and Abdomen Analysis Lung Analysis Resection Synapse 3D Perfusion Analysis Synapse 3D Blood Flow Analysis Synapse 3D Liver and Kidney Analysis Liver Analysis Kidney Analysis Synapse 3D Base Tools (V7.2) Synapse 3D Colon Analysis Synapse 3D Tensor Analysis Synapse 3D Nodule Analysis Synapse Lung Nodule AI Synapse 3D Brain Perfusion

    Establishment Types

    Manufacture Medical Device