BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SonoSite SII Ultrasound System

    Reg #: 3032367 · FEI: 3002087856 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    FUJIFILM SONOSITE,INC.
    Registration Number
    3032367
    FEI Number
    3002087856
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    21919 30th Dr SE
    City
    BOTHELL
    State
    WA
    ZIP
    98021
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162045

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

    Proprietary Names

    SonoSite SII Ultrasound System SonoSite Edge II Ultrasound System

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Remanufacture Medical Device