BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FUJIFILM SONOSITE,INC.

    Reg #: 3032367 · FEI: 3002087856 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    56
    Establishment Types
    4
    Classifications
    8

    Registration Details

    Registration Name
    FUJIFILM SONOSITE,INC.
    Registration Number
    3032367
    FEI Number
    3002087856
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    21919 30th Dr SE
    City
    BOTHELL
    State
    WA
    ZIP
    98021
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200964

    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
    Biopsy Needle Guide Kit OIJ
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Image Processing, Radiological LLZ
    Automated Radiological Image Processing Software QIH
    Plethysmograph, Impedance DSB
    System, Digital Image Communications, Radiological LMD

    Proprietary Names

    Sonosite PX Ultrasound System SonoSite SII Ultrasound System Edge Ultrasound System S-ICU Ultrasound System SonoSite Maxx Series Ultrasound System M-Turbo Ultrasound System S-Women's Health Ultrasound System S-Nerve Ultrasound System S-Cath Ultrasound System S Series Ultrasound System S-MSK Ultrasound System M-MSK Ultrasound System M-OB/Gyn Ultrasound System S-FAST Ultrasound System MicroMaxx Ultrasound System MicroMaxx High-Resolution Ultrasound System SonoSite MicroMaxx Ultrasound System iViz Ultrasound System SonoSite X-Porte Ultrasound System Cable, Leadwires, ECG External ECG Connector Cable and Adapter C5-1 MHz Transducer C10-3 MHz Transducer IC10-3 MHz Transducer L12-3 MHz Transducer L15-4 MHz Transducer P5-1 MHz Transducer T8-3 MHz Transducer Sonosite ECG Module Leadwires Sonosite LX Ultrasound System Sonosite ECG Module L19-5 MHz Transducer Sonosite ZX Ultrasound System Sonosite ST Ultrasound System NanoMaxx Ultrasound System Maxx Series Ultrasound System UHF46-20 Transducer SonoSite Edge II Ultrasound System X-Porte Ultrasound System X-Porte Ultrasound Kiosk SonoSite Vevo MD Imaging System Vevo MD Imaging System FUJIFILM SonoSite Vevo MD Imaging System SonoSite iViz Ultrasound System SonoSite NanoMaxx Series Ultrasound System Axo Track Exact Track Sonosite MT Ultrasound System SonoSite Ultrasound System Titan High-Resolution Ultrasound System FUJIFILM FC1 Ultrasound System S-Series Ultrasound System Bio Z Cardio Profile SonoSite NanoMaxx Ultrasound System L25 Needle Guide iLook 25 Needle Guide Attachment and Bracket Assembly

    Establishment Types

    Remanufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility