BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FUJIFILM Healthcare Americas Corporation

    Reg #: 3008491142 · FEI: 3008491142 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    FUJIFILM Healthcare Americas Corporation
    Registration Number
    3008491142
    FEI Number
    3008491142
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    81 Hartwell Ave Ste 100
    City
    Lexington
    State
    MA
    ZIP
    02421
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210811

    Owner / Operator

    Firm Name
    FUJIFILM Healthcare Americas Corporation
    Operator Number
    10043450
    Address
    81 Hartwell Avenue, Suite 100
    City
    Lexington
    State
    MA
    Postal Code
    02421
    Country
    US
    Correspondent
    Randy Vader

    Products

    Device Name Product Code
    Whole Slide Imaging System PSY
    Digital Pathology Image Viewing And Management Software QKQ

    Proprietary Names

    Synapse Pathology Software

    Establishment Types

    Manufacture Medical Device