BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FUJIFILM Healthcare Americas Corporation

    Reg #: 3004972322 · FEI: 3004972322 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    FUJIFILM Healthcare Americas Corporation
    Registration Number
    3004972322
    FEI Number
    3004972322
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    79 TW Alexander Drive, Building 4501
    City
    Durham
    State
    NC
    ZIP
    27709
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190232

    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

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Automated Radiological Image Processing Software QIH
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    Synapse PACS 7.X Synapse PACS Synapse Enterprise Viewer Synapse CardioVascular Synapse PACS 5.X Synapse PACS 7.5 Synapse Select VIDISTAR PACS

    Establishment Types

    Manufacture Medical Device